Composition containing 1,8-cineole for therapeutic use

Abstract

Cineole for use in reducing pathogenic germs in the human intestine and in reducing the colonization of the human intestine with pathogenic germs and equally for use in increasing the colonization of the human intestine with health-promoting or non-pathogenic germs.

Description

[0001] The present invention relates to the technical (i.e. medical-pharmaceutical) field of the microbiome of the human intestine and in particular of the human intestinal flora and, more specifically, of inflammatory diseases of the human body, which are particularly associated with pathogenic germs in the intestinal flora or an incorrect colonization of the intestine or are caused or exacerbated thereby.

[0002] The present invention specifically relates to an active ingredient and a medicament or a composition, each for use in reducing pathogenic germs in the human intestine or for use in reducing the colonization of the human intestine with pathogenic germs, preferably for the purposes of preventing, reducing, or curing inflammatory diseases or preferably for the purposes of the prophylactic or therapeutic treatment of inflammatory diseases of the human body. Likewise, the present invention also relates to an active ingredient and a medicament or a composition, each for use in the prophylactic or therapeutic treatment of dysbiosis or incorrect colonization of the human intestine. Correspondingly, the present invention also relates to a related use of an active ingredient and a medicament or a composition.

[0003] According to the invention, the active ingredient used is cineole, preferably 1,8-cineole, or a medicament containing this active ingredient or a corresponding composition.

[0004] Furthermore, the present invention also relates to a pharmaceutical combination based on the active ingredient used according to the invention in the form of cineole, preferably 1,8-cineole.

[0005] The human digestive tract, or gastrointestinal tract, is generally composed of organs that serve to absorb, break down, and transport food. Metabolic processes occur within the digestive tract that lead to the release or breakdown of nutrients contained in food so that they are available to the body in a usable form and enable absorption of nutrients into the body. In the digestive tract, the food undergoes mechanical and enzymatic digestion, followed by the absorption of nutrients, electrolytes, and water, as well as the excretion of indigestible or unusable food components from the body.

[0006] The human intestine, including the small and large intestines, plays a significant role in the breakdown and absorption of nutrients, electrolytes, and water. In addition to enzymes, numerous microorganisms that colonize the intestines are also involved in digestion. The totality of microorganisms that colonize the human intestine is referred to as the intestinal flora, which represents a separate and independent human microbiome. In this context, the intestine and its underlying intestinal flora represent a complex and dynamic bacterial ecosystem that establishes itself during the first years of life and develops with increasing age, undergoing changes that may also be pathological in nature. The intestinal flora is characterized by the presence of a large number of different bacterial families and genera and the associated underlying species.

[0007] Undesirable changes in the intestinal flora can be caused, for example, by an incorrect diet, the consumption of contaminated food or the excessive use of medications such as antibiotics, cortisone or the like. Excessive alcohol consumption can also lead to undesirable changes in the intestinal flora. Changes in the intestinal flora can be accompanied by under- or over-colonization as well as a change in the bacterial composition, which can occur in both the large intestine and the small intestine. Intestinal colonization, which is particularly associated with an excessive presence or excessive growth of pathogenic germs in the intestinal flora, can persist for long periods of time and thus become chronic. The imbalance in the intestinal flora resulting from intestinal colonization is generally referred to as dysbiosis orDysbacteriosis refers to an excessive presence of harmful or pathogenic foreign flora in the intestine.

[0008] Numerous approaches to influencing the intestinal flora are known in the state of the art, with a particular focus on the treatment of acute disturbances of the intestinal flora, particularly with regard to alleviating or preventing diarrhea symptoms or diseases associated with acute impairments of the intestinal flora, such as the common traveler's diarrhea. This is an infectious disease of the intestine caused by pathogenic bacteria or their toxins, with pathogenic, enterotoxin-producing bacteria of the Escherichia coli (ETEC) type being involved in more than 50% of cases. The fluid loss associated with diarrhea can lead to dehydration, accompanied by significant electrolyte loss and subsequent electrolyte deficiency.

[0009] Current technology often involves the use of pharmaceutical preparations that reduce or suppress intestinal activity to treat diarrhea, such as the active ingredient loperamide, which is an opioid. The underlying effect is a reduction in intestinal peristalsis, thereby alleviating diarrhea symptoms. However, this hinders or delays the excretion of pathogens or toxins. Specifically with regard to acute diarrhea associated with intestinal overgrowth, current technology also includes the administration of electrolytes or minerals, which may also be combined with glucose, particularly in the form of aqueous solutions. While this can compensate for electrolyte and fluid loss, it does not combat the pathogens that cause diarrhea.In addition, the current state of the art also considers the administration of live or viable microorganisms, particularly for the treatment of diarrhea. However, the efficacy of such applications is not always sufficient.

[0010] In addition, with regard to diarrheal diseases associated with incorrect colonization of the intestine, preparations based on prebiotic components and microorganisms that influence the intestinal flora are also used in the prior art. DE 10 2008 059 070 A1, for example, relates to a composition which is to be used in particular for the therapeutic or prophylactic treatment of diarrheal diseases, wherein the composition in question contains microorganisms and at least one prebiotic. This is intended to support the body's own natural intestinal flora. On this basis, relatively good effects can be achieved with regard to the treatment of acute diarrheal symptoms or diseases. However, a targeted influence on or adjustment of the intestinal flora is sometimes not possible on this basis, in particular not with regard to the aspect of improving the immune system provided by the intestinal microbiome.the intestinal flora influenced immune system or the underlying immune status and associated or related inflammatory diseases that also occur on a physical or systemic level.

[0011] In addition to its important digestive function, such as the further breakdown of nutrients, the intestinal flora and the associated germs and bacteria also play a significant role in the immune system and inflammatory processes in the human body, for example, in the defense against and combating pathogens, as well as in further immune modulation and influencing inflammatory processes. The intestinal flora and the intestinal microbiome also exert a significant regulatory influence on inflammatory processes and the associated immune regulation. In addition to negatively impacting digestive function, excessive intestinal colonization with pathogenic germs, or dysbiosis, is often associated with adverse effects on the immune system and underlying immune (defense) reactions and regulations.

[0012] It is also noteworthy that in the human body, approximately 70% to 80% of all (immune) cells capable of producing antibodies are located in the intestinal mucosa or intestinal epithelium. Such antibody-producing cells require an intact intestinal flora to function optimally. Accordingly, a sustained disruption of the intestinal flora, or dysbiosis, can also impact such immune-relevant cells, resulting in an underfunction or dysfunction of the immune system, also with regard to inflammatory processes in the human body as a whole.

[0013] In addition, pathogenic germs or pathogenic bacteria can possess properties that initiate or influence inflammatory reactions and thus lead to corresponding inflammatory diseases or exacerbate or modulate inflammatory diseases, such as the production or release of corresponding inflammatory substances, which are also relevant at the (whole) body level. An incorrect colonization of the intestine can thus influence the immune system, associated with an increased susceptibility to infections or an undesirable exacerbation or initiation of inflammatory processes.

[0014] An incorrect colonization of the human intestine is all the more problematic with regard to its influence on immune- or inflammatory-relevant processes, as the presence of pathogenic germs in the intestine and the presence of a weakened intestinal epithelium, for example, can increase their negative effect on the immune system or inflammatory processes in an undesirable manner.

[0015] The consequences of intestinal colonization or dysbiosis not only lie in a negative impact on digestive function as such, but also in a negative influence on the immune status of an affected patient, also with regard to the influencing or inducing of inflammatory processes and the associated immune regulation. A colonization of the human intestine with pathogenic germs or a change in the immune status or the strength of the immune system caused by dysbiosis can also have a corresponding impact on the overall body processes of an affected patient. Such intestinal colonization or dysbiosis can sometimes also lead to a greater susceptibility to infections or inflammatory diseases overall or to inflammatory reactions at the overall body level, also with regard to the influencing or inducing of inflammatory processes.Modulation of inflammatory diseases or processes occurring or already present in the body as a whole. Consequently, dysbiosis or dysbiosis has an effect on the human body as a whole that extends beyond the human intestine as the site of its occurrence, particularly with regard to a regulatory influence on inflammatory processes and corresponding immunoregulatory processes, so that diseases or inflammatory processes in the body as a whole can be influenced or exacerbated on this basis.

[0016] The online excerpt "Oblas - Magen & Darm" (Oblas - Stomach & Intestine) from www.olbas.de / de / anwendungsgebiet / magen-darm generally refers to essential oils from peppermint, cajeput, and eucalyptus with regard to their use for mild, cramp-like gastrointestinal complaints. The effect of several oils is suggested, particularly peppermint menthol and the chemically related cineole found in cajeput and eucalyptus.

[0017] DE 35 11 862 A1 relates to a pharmaceutical preparation in the form of fluid extracts, wherein the composition contains extractives from Carum carvi as component A, extractives from Foeniculum vulgare as component B, and extractives from a plant containing terpene ketones, terpene ethers, terpene alcohols, or phenol derivatives of terpenes as component C. The preparation is also said to contain ethanol and water.

[0018] Furthermore, WO 2013 / 026556 A1 relates to a combination therapeutic agent comprising at least one vitamin D receptor agonist (VDA) and at least one monoterpene. Its primary use is the treatment of inflammatory respiratory diseases.

[0019] In light of the above statements, there is therefore a great need - particularly due to the sometimes significant impact of incorrect colonisation of the intestine with pathogenic germs or dysbiosis on the overall state of health or the immune status - to provide suitable forms of therapy based on efficient active substances or related compositions and medicinal products which are effectively suitable for reducing pathogenic germs in the human intestine or in the human intestinal flora, also against the background of improving the immune status or preventing or reducing inflammatory diseases of the human body as a whole, which are particularly present in connection with underlying incorrect colonisation of the human intestine with pathogenic germs or are caused or negatively influenced or exacerbated thereby.

[0020] The present invention therefore aims to provide an efficient concept, or related active ingredients and compositions, as well as medicaments, which, when used or applied, lead to a reduction in pathogenic germs in the human intestine or to a reduction in the colonization of the human intestine with pathogenic germs and thus to a normalization or improvement of the human intestinal flora. In this regard, a reduction, prevention, or cure of inflammatory diseases of the human body or a corresponding treatment of inflammatory diseases of the human body should also be enabled. In addition to good efficacy, excellent tolerability and ease of use should also be ensured.

[0021] Likewise, yet another object of the present invention is to provide corresponding active ingredients as well as compositions and medicaments based thereon, which are suitable for the particularly prophylactic and / or therapeutic treatment of dysbiosis or incorrect colonization of the human intestine as such with pathogenic germs, in particular with regard to a further positive influence on inflammatory diseases of the human body as a whole, wherein in this respect, good tolerability and simple application should also be ensured with high efficacy.

[0022] A further object of the present invention is also to provide corresponding active substances or compositions and medicaments based thereon with a view to reducing pathogenic germs in the human intestine or with a view to reducing the colonization of the human intestine with such pathogenic germs, which at least largely avoid or at least mitigate the disadvantages of the prior art described above.

[0023] In a completely surprising way, the applicant has now discovered that cineole, in particular 1,8-cineole, is unexpectedly and efficiently suitable as an active ingredient for a sustainable reduction of pathogenic germs in the human intestine or for a corresponding reduction of the colonisation of the human intestine with pathogenic germs, and furthermore also in connection with the prevention, reduction or cure of inflammatory diseases of the human body which in particular are accompanied by such incorrect colonisation or are related to this or are caused by pathogenic germs of the intestinal flora or are induced or increased thereby.

[0024] To solve the problem described above, the present invention therefore proposes - according to a first aspect of the present invention - cineole for use in reducing pathogenic germs in the human intestine or for use in reducing the colonization of the human intestine with pathogenic germs or for use in increasing the colonization of the human intestine with health-promoting or non-pathogenic germs according to patent claim 1. Advantageous further developments and refinements of this aspect of the invention are the subject of the relevant subclaims. According to the present aspect, the present invention also relates to cineole for use in the prophylactic or therapeutic treatment of dysbiosis or incorrect colonization of the human intestine with pathogenic germs according to the relevant subclaim.Advantageous further developments and embodiments of this aspect of the invention are the subject of the respective subclaims.

[0025] A further subject matter of the present invention—according to a second aspect of the present invention—is the inventive use of cineole (for the production of a medicament or drug) for reducing pathogenic germs in the human intestine and for reducing the colonization of the human intestine with pathogenic germs, as well as for increasing the colonization of the human intestine with health-promoting or non-pathogenic germs, according to the relevant independent patent claims. According to the present aspect, the present invention also relates to the use of cineole for the prophylactic or therapeutic treatment of dysbiosis or incorrect colonization of the human intestine with pathogenic germs, according to the relevant independent claim. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaims.

[0026] The present invention also relates—according to a third aspect of the present invention—to a pharmaceutical or medicament for use in reducing pathogenic germs in the human intestine, or for use in reducing the colonization of the human intestine with pathogenic germs, according to the relevant independent patent claim. According to this aspect, the present invention also relates to a pharmaceutical or medicament for the prophylactic or therapeutic treatment of dysbiosis or incorrect colonization of the human intestine with pathogenic germs, according to the relevant independent claim. Advantageous further developments and refinements of this aspect of the invention are the subject of the relevant subclaims.

[0027] Likewise, the present invention—according to a fourth aspect of the present invention—provides a pharmaceutical composition for use in reducing pathogenic germs in the human intestine, or for use in reducing the colonization of the human intestine with pathogenic germs, and equally for use in increasing the colonization of the human intestine with health-promoting or non-pathogenic germs, according to the relevant independent patent claim. According to this aspect, the present invention also relates to a related pharmaceutical composition for use in the prophylactic or therapeutic treatment of dysbiosis or incorrect colonization of the human intestine with pathogenic germs, according to the relevant independent claim. Advantageous further developments and refinements of this aspect of the invention are the subject of the relevant subclaims.

[0028] Finally, the subject matter of the present invention—according to a fifth aspect of the present invention—is equally a pharmaceutical combination for use in reducing pathogenic germs in the human intestine, or for use in reducing the colonization of the human intestine with pathogenic germs, and equally for use in increasing the colonization of the human intestine with health-promoting or non-pathogenic germs, according to the relevant independent patent claim. In this context, the present invention also relates to a pharmaceutical combination for use in the prophylactic or therapeutic treatment of dysbiosis or incorrect colonization of the human intestine, according to the relevant independent claim. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaims.

[0029] It goes without saying that embodiments, forms of embodiment, advantages and the like which are listed below for the purpose of avoiding repetition of one aspect of the invention naturally also apply accordingly to the other aspects of the invention without this requiring separate mention.

[0030] Furthermore, with regard to the following description of the present invention, the features of the present invention cited in connection with the specific configurations, embodiments, advantages, examples, or the like are also deemed to be disclosed in their combination. Thus, higher-level combinations of individual or multiple features cited for respective configurations, embodiments, application examples, or the like are also deemed to be disclosed.

[0031] Furthermore, it goes without saying that the following specifications of values, numbers, and ranges are not to be understood as limiting; it is self-evident to the person skilled in the art that, depending on the individual case or application, deviations from the specified range or specifications may occur without departing from the scope of the present invention.

[0032] In addition, all values ​​or parameters or the like mentioned below can generally be determined using standardized or explicitly specified determination procedures or using determination methods that are familiar to a person skilled in the art.

[0033] Furthermore, with all relative or percentage quantities, particularly weight-related quantities, mentioned below, it should be noted that these quantities must be selected or combined by the person skilled in the art within the scope of the composition according to the invention in such a way that the total – optionally including other components or ingredients or additives or constituents, in particular as defined below – always amounts to 100% or 100% by weight. However, this is self-evident to the person skilled in the art.

[0034] Furthermore, the term "medication" or "drug" (also synonymously "pharmaceutical"), as used in the context of the present invention, is to be understood very broadly and encompasses not only medicines or pharmaceuticals as such (i.e., in terms of pharmaceutical law), but above all also so-called medical devices, and beyond that, homeopathic remedies and dietary supplements, as well as cosmetics and consumer goods. In other words, the composition according to the invention can be in the form of a medicine (pharmaceutical), medical device, homeopathic remedy, dietary supplement, cosmetic, or consumer goods.

[0035] Having said that, the present invention will now be explained in detail below.

[0036] The subject matter of the present invention - according to a first aspect of the present invention - is thus cineole for use in reducing pathogenic germs in the human intestine and in reducing the colonization of the human intestine and equally for use in increasing the colonization of the human intestine with health-promoting or non-pathogenic germs.

[0037] The cineole is preferably 1,8-cineole.

[0038] Preferably, cineole is used within the scope of the invention for the purposes of preventing, reducing or curing inflammatory diseases of the human body and / or for the purposes of prophylactic and / or therapeutic treatment of inflammatory diseases of the human body.

[0039] The term "human intestine" is to be understood very broadly within the scope of the present invention and refers in particular to the section of the digestive tract extending from the pylorus to the anus. In particular, the term in question refers to the small intestine and / or large intestine section of the human intestine. Thus, the present invention also relates in particular to cineole, preferably 1,8-cineole, for use in reducing pathogenic germs in the human small intestine and / or large intestine, in particular in the human intestinal flora of the small intestine and / or large intestine.for use in reducing the colonization of the human small intestine and / or large intestine, in particular the human intestinal flora of the small intestine and / or large intestine, with pathogenic germs, preferably for the purposes of preventing, reducing or curing inflammatory diseases of the human body and / or preferably for the purposes of prophylactic and / or therapeutic treatment of inflammatory diseases of the human body.

[0040] In the context of the present invention, cineole is used or employed in particular to reduce the germ load or the number of pathogenic germs in the human intestine or in particular to reduce the proportion of pathogenic germs, based on the total number of germs in the human intestine, in particular in the human intestinal flora.

[0041] As previously stated, the applicant has discovered, quite surprisingly, that cineole, in particular 1,8-cineole, is unexpectedly and effectively suitable as an active ingredient for reducing pathogenic germs in the human intestine or for reducing the colonization of the human intestine with pathogenic germs, particularly for the purposes of preventing, reducing, or curing inflammatory diseases of the human body or, in particular, for the purposes of the prophylactic and / or therapeutic treatment of inflammatory diseases of the human body. In this context, the present active substance is equally suitable for the prophylactic or therapeutic treatment of dysbiosis or related colonization of the human intestine.

[0042] On the basis of the present invention, through the targeted and purposeful use of cineole, preferably 1,8-cineole, a selective reduction in pathogenic germs in the intestine and / or a corresponding increase in non-pathogenic or health-promoting germs in the intestine can be achieved, so that on the basis of the inventive concept, an overall positive change or influence on the human intestinal flora with regard to its germ composition is achieved. According to the invention, the use of cineole, in particular 1,8-cineole, thus results in a significant shift in the microbial and in particular the bacterial composition of the intestinal microbiome, to the extent that pathogenic and thus harmful germs or germs associated with inflammation are sustainably reduced in the intestinal flora. This also reduces the presence of inflammation-relevant substances.Inflammatory mediators originating from pathogenic germs are reduced.

[0043] On the basis of the surprisingly discovered targeted change or influence on the microbiome of the human intestine or the human intestinal flora by cineole, preferably 1,8-cineole, with the reduction of pathogenic germs, a so to speak holistic or systemic effect is achieved in this context - without wishing to invoke or limit oneself to this theory - as was equally found in a completely surprising way within the scope of the present invention, namely in that inflammatory diseases or inflammatory processes in the human body as a whole can be positively influenced or controlled in the sense of a reduction, avoidance or healing, and in addition to the human intestine itself as the primary site of action for cineole, in particular 1,8-cineole, also in other organs or systems different from the human intestine.Body regions, such as the mouth / throat area or the throat / nose / ear area (as explained below), or on a physical or systemic level as a whole. The positive effect on the intestinal flora, which is achieved according to the invention and reduces corresponding pathogenic germs, can improve the immune status or the immune system as a whole, particularly to the extent that inflammatory processes or inflammatory diseases can be avoided, reduced, or even cured on this basis.

[0044] In this context, the applicant has also discovered, quite surprisingly, that inflammatory diseases in the human body, such as inflammatory diseases of the mouth / throat area or the throat / nose / throat area, such as rhinosinusitis or the like, can be associated with an overgrowth of pathogenic germs in the human intestine or with an excessive presence of pathogenic germs in the human intestinal flora. Consequently, the present invention also provides an effective and previously undescribed or unimagined approach to using cineole, preferably 1,8-cineole, to specifically influence the intestinal flora, thereby enabling, for the first time, associated inflammatory diseases of the human body to be treated prophylactically or therapeutically.

[0045] In this regard, within the scope of the present invention, it is particularly such that, with simultaneous treatment or therapy of abnormal or pathological conditions of the intestinal microbiome or the human intestinal flora, a corresponding reduction or suppression of inflammatory processes in the body occurs, which is further accompanied by a positive effect on inflammatory diseases or conditions of the human body as a whole, so that according to the invention, for the first time, a holistic therapy concept is provided with regard to incorrect colonization of the intestine and the associated inflammatory processes or diseases of the body.

[0046] On the basis of the inventive concept with the use of cineole, preferably 1,8-cineole, for reducing pathogenic germs in the human intestine for the purposes of preventing, reducing or curing inflammatory diseases of the human body - equally without wishing to invoke or limit oneself to this theory - systemic inflammatory parameters are also positively influenced in particular, so that on this basis too there is an overall positive and in particular anti-inflammatory or regulating effect with regard to the treatment of further inflammatory diseases of the human body, which may be present not only in the area of ​​the intestine itself, but also in other or different parts or regions of the body, as explained in more detail below.

[0047] According to the invention, through the targeted use of cineole, preferably 1,8-cineole, for the purpose of reducing the colonization of the human intestine or the human intestinal flora with pathogenic germs - without wishing to be limited to or invoke this theory - a holistic or systemic approach is provided for the first time with regard to the associated positive effect on inflammatory diseases of the human body, wherein, moreover, according to the invention, a so-called universal and, with regard to the inflammatory disease of the human body, non-specific or generally valid approach is provided, which leads to the possibility of treating a large number of different inflammatory diseases, since, according to the invention, so-called higher-level relevant immune or inflammation-regulatory processes can be positively influenced or regulated.

[0048] According to the invention, in this context, cineole, preferably 1,8-cineole, has a dysbiotic effect, in particular one that counteracts the overgrowth of pathogenic bacteria in the human intestine. In this regard, cineole, preferably 1,8-cineole, can in particular have an effect that improves or regulates the systemic immune status of the human body, in particular an effect that induces inflammation.

[0049] Due to the anti-dysbiotic effect of cineole, preferably 1,8-cineole, which was discovered completely surprisingly within the scope of the present invention, an overall anti-inflammatory effect is provided, even at the systemic level, whereby this effect - without wishing to be limited or invoked by this theory - is based on several factors: Thus, (i) on the one hand, at the primary site of action, namely the human intestine, there is a positive effect on the intestinal epithelium and the immune cells present there, particularly based on the reduction of pathogenic germs in the human intestinal microbiome, so that their negative influence on the intestinal epithelium is reduced or prevented, leading to an improvement or regulation of the relevant immune status (induction of active or primary anti-inflammatory mediation). Furthermore, (ii) on the other hand, the reduction or elimination of pathological germs in the human intestine caused by the administration of cineole, preferably 1,8-cineole, reduces or prevents the presence or release of corresponding inflammation-relevant substances, such as inflammatory mediators or the like, which originate from the pathogenic germs (induction of passive or secondary anti-inflammatory mediation).In addition, within the scope of the present invention, and in particular in addition to (i) and (ii), it can also behave in such a way that (iii) excess cineole or 1,8-cineole (i.e. which is not required for the anti-dysbiotic effect in the intestine or is used up for this purpose) is systemically absorbed or taken up and can, for example, develop a corticosteroid-like effect profile in the blood system, so that a supplementary anti-inflammatory effect can also be exerted on this basis.

[0050] Through the interplay and reinforcement of the underlying effects, the invention results in a sustained anti-inflammatory effect that is not limited to the intestine itself, but also extends throughout the intestine and thus has a positive impact on the entire body. This also includes a region- or organ-nonspecific anti-inflammatory effect, or a general systemic anti-inflammatory effect with a corresponding downregulation of inflammatory processes overall, resulting in a high level of efficacy and broad range of effects, which is relevant for a large number of different inflammatory diseases and inflammatory reactions in the human body.

[0051] The specific, new and inventive application or medical indication for cineole, in particular 1,8-cineole, which the applicant has surprisingly discovered within the scope of the present invention, has not been described or recognized in the prior art to date, although cineole, in particular 1,8-cineole, is in itself a sufficiently well-known active ingredient.

[0052] The active ingredient used in the invention, cineole, in particular 1,8-cineole, is a so-called terpene, in particular a monoterpene. Terpenes are generally natural substances which can be isolated as components of so-called essential oils in the form of liquids from plants or their components. They are often fragrances and flavorings which are used in the food or cosmetics industry. In addition, the use of terpenes for medicinal purposes is also gaining importance, as pharmacological effects can be demonstrated for a large number of terpenes. Terpenes are formally polymerization products of isoprene, whereby the number of isoprene residues distinguishes between monoterpenes (C 10 -units), sesquiterpenes (C 15 -units), diterpenoids (C 20 -units), sesterterpenes (C 25 -units), triterpenes (C 30 -units), tetraterpenes (C40 -units) and polyterpenes (cf. RÖMPP-Chemielexikon, 10th edition, Georg Thieme Verlag, Stuttgart / New York, 1999, pages 4449 and 4450, keyword “terpene(oid)s”). In addition, terpenes can also be used as pharmacologically active substances, starting materials for the production of medicines or vitamin preparations, and in agriculture due to their often bactericidal or pesticidal effects. Pharmacological effects in the control of diseases in systemic treatments have been proven for a number of monoterpenes in particular, with menthol and cineole, especially 1,8-cineole, being particularly noteworthy.

[0053] The active ingredient used in the invention, cineole, in particular 1,8-cineole, belongs to the bicyclic epoxy monoterpenes, more specifically to the limonene oxides. Synonyms for 1,8-cineole with the chemical formula C 10 H 18O are eucalyptol, limonene-1,8-oxide, 1,8-epoxy-p-menthane, or 1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane. It is a colorless liquid with a spicy, camphor-like odor, a melting point of +1.5 °C and a boiling point of 176 to 177 °C. It is insoluble in water but miscible with most organic solvents.

[0054] 1,8-cineole occurs naturally as the main component of eucalyptus oil (eucalyptus oil contains up to 85% by weight of 1,8-cineole), but also in other plants, such as mint, medicinal sage, thyme, basil, and tea tree. 1,8-cineole is also found in niaouli, juniper, piper, cannabis, cajuput, sage, myrtle, and other essential oils.

[0055] Technically or pharmaceutically purified 1,8-cineole, which can generally be obtained with a purity of 99.6% to 99.8%, is generally obtained by fractional distillation of eucalyptus oil.

[0056] According to the state of the art, 1,8-cineole is used both topically (e.g. inhalation) and systemically (e.g. in the form of capsules), usually as a mixed oil together with a variety of other terpenes.

[0057] For further details on the active ingredient 1,8-cineole, reference can be made to RÖMPP Chemielexikon, Georg Thieme Verlag, Stuttgart / New York, 10th edition, Volume 1, 1996, page 752, keyword: “Cineole”, as well as the literature cited therein.

[0058] Due to the lipophilicity of the cineole, in particular 1,8-cineole, which is preferably administered orally according to the invention, and in particular in a gastric juice-resistant or small intestine-soluble form, as also stated below, long-term storage in the relevant epithelial cells of the intestine can also be assumed, so that a long-term and uniform supply of cineole, in particular 1,8-cineole, is ensured with regard to the intestinal system.

[0059] The defined effectiveness of the cineole, in particular 1,8-cineole, used according to the invention can - again without wishing to be bound to a specific theory - possibly also be attributed to the additionally present and surprisingly discovered by the applicant steroid-like effect potential of cineole, in particular 1,8-cineole, in particular with regard to a further or additional inhibition of inflammatory mediators, ie cineole, in particular 1,8-cineole, in particular as a pure substance, can also have a steroid-like effect potential.Essential mixed oils, on the other hand (which contain cineole in a mixture with other terpenes and other active ingredients), stimulate prostaglandin production and, compared to pure cineole, especially pure 1,8-cineole, as preferably used according to the invention, exhibit only reduced inhibition of, for example, leukotriene and cytokine production. Such mixed oils also contain substances that stimulate cell activity and mediator production and therefore do not have an anti-inflammatory effect, but can cause intolerance reactions. Consequently, essential mixed oils or oil mixtures generally even increase cell activity and can induce inflammatory mediator production. In contrast, however, cineole, especially 1,8-cineole, especially in its pure form, can cause a significant inhibition of mediator production; this can also support an anti-inflammatory effect.

[0060] In the context of the present invention, the pathogenic germs are in particular selected from the group of inflammation-causing (inflammation-inducing), inflammation-promoting and inflammation-associated germs in the human body or causing such, in particular from the group of germs producing and / or releasing inflammation-causing and / or inflammation-promoting substances, as well as combinations thereof.

[0061] Thus, according to the invention, these can be, in particular, pathogenic germs which, due to their specific properties, for example and without limitation with regard to the production of pro-inflammatory substances or the like, have a corresponding influence on inflammatory processes in the human body, in particular with regard to an inflammation-promoting, inducing, or initiating effect. These can also be inflammatory mediators originating from the pathogenic germs, which can, in particular, also exert systemic or cross-intestinal inflammatory effects (for example, through systemic absorption of these substances or the underlying germs).

[0062] According to the invention, it is particularly provided that the pathogenic germs are selected from the group of bacteria, in particular bacteria that negatively affect health and / or are harmful to health, preferably from the group of bacteria that cause inflammation, bacteria that induce inflammation and bacteria that are associated with or cause inflammation in the human body, as well as combinations thereof.

[0063] According to a preferred embodiment of the invention, the pathogenic germs are selected from the group of bacteria from the Prevotellaceae family, preferably from the group of bacteria from the genus Prevotella. Bacteria from the Prevotellaceae family or the genus Prevotella are often involved in infections or inflammatory processes.

[0064] Bacteria of the genus Prevotella are primarily Gram-negative, obligate anaerobic species that are pleomorphic, rod-shaped, immobile, and sporeless. They exhibit a chemoorganotrophic fermentation metabolism whose main end products are acetate and succinate. The genus Prevotella generally includes approximately 40 different species, which can often cause or exacerbate various inflammatory processes, for example, in the oral cavity or the respiratory tract.

[0065] The applicant has surprisingly discovered that bacteria of the Prevotellaceae family, in particular of the bacterial genus Prevotella, are present in increased quantities in the intestine of patients suffering from nasal polyposis, and that the proportion or number thereof can be sustainably reduced in an equally surprising manner by administering cineole, preferably 1,8-cineole, as will be shown below.

[0066] Within the scope of the present invention, cineole, preferably 1,8-cineole, is furthermore, additionally, or equally used to increase, multiply, or support health-promoting or non-pathogenic, preferably health-promoting, microbes in the human intestine, particularly in the human intestinal flora. The applicant has discovered, both unexpectedly and surprisingly, that the proportion or number of such beneficial microbes in the human intestine can be significantly increased with the use of cineole or 1,8-cineole.

[0067] In this regard, in addition to a reduction in pathogenic germs, an increase, proliferation, or support of health-promoting or non-pathogenic germs can also be achieved through the targeted administration of cineole, preferably 1,8-cineole, so that the overall composition of the microbiome of the human intestine or the intestinal flora can be improved or normalized on this basis. Thus, within the scope of the present invention, the cineole used, preferably 1,8-cineole, also has a multiple effect, namely, on the one hand, with regard to a reduction in pathogenic germs and, on the other hand, a targeted support of health-promoting or non-pathogenic germs in the human intestine.

[0068] According to the invention, cineole, preferably 1,8-cineole, is equally used or employed for use in increasing the colonization of the human intestine, in particular the human intestinal flora, with health-promoting or non-pathogenic, preferably health-promoting, germs.

[0069] In general, within the scope of the present invention, the health-promoting or non-pathogenic, preferably health-promoting, germs can be selected from the group of inflammation-reducing, anti-inflammatory, and inflammation-inhibiting germs, in particular from the group of germs that produce and / or release anti-inflammatory and inflammation-inhibiting substances, as well as combinations thereof. In particular, the health-promoting or non-pathogenic germs in question can be germs that produce or release anti-inflammatory substances. This can also lead to a targeted reduction or inhibition of inflammatory processes in the human body.

[0070] By reducing pathogenic germs, in particular those with a pro-inflammatory effect, on the one hand, and supporting health-promoting or non-pathogenic germs, in particular those with an anti-inflammatory effect, on the other hand, a dual approach is achieved within the scope of the present invention with regard to an inflammation-reducing or anti-inflammatory or inhibiting effect in connection with the administration of cineole, preferably 1,8-cineole, so that a very high level of effectiveness is therefore also achieved, not only with regard to inflammatory processes or diseases in the human intestine itself, but also with regard to systemic or local inflammations which affect other areas of the human body or areas different from the human intestine, as will be explained in more detail below.

[0071] According to a preferred embodiment of the invention, the health-promoting or non-pathogenic, preferably health-promoting, germs are selected from the group of bacteria, in particular bacteria that have a positive influence on health and / or are health-promoting, preferably from the group of inflammation-reducing, anti-inflammatory and inflammation-inhibiting bacteria, as well as combinations thereof.

[0072] In particular, within the scope of the present invention, it can be provided that the health-promoting or non-pathogenic, preferably health-promoting, germs are selected from the group of bacteria of the Ruminococcacea family, preferably from the group of bacteria of the Ruminococcus genus. With regard to bacteria of the Ruminococcacea family or the Ruminococcus genus, these are in particular bacteria that produce anti-inflammatory short-chain fatty acids, such as butyrate, so that the bacteria in question can be attributed a positive effect with regard to reducing inflammatory processes in the human body.

[0073] According to the invention, it can also be provided that the health-promoting or non-pathogenic, preferably health-promoting, germs are selected from the group of bacteria of the families Bacteroidaceae, Lachnospiraceae, and Bifidobacteriaceae, in particular Bacteroidaceae and Lachnospiraceae, preferably Bacteroidaceae, and combinations thereof. In particular, it can specifically be provided according to the invention that the health-promoting or non-pathogenic, preferably health-promoting, germs are selected from the group of bacteria of the genus Bacteroides, Lachnospira, and Bifidobacterium, in particular Bacteroides and Lachnospira, preferably Bacteroides, and combinations thereof. Bacterial species belonging to the aforementioned families or genera can also be associated with a positive effect on the human intestinal flora or with anti-inflammatory effects.

[0074] With regard to cineole, preferably 1,8-cineole, the invention also provides for its use or application to regenerate and / or remediate the bacterial colonization of the human intestine, in particular the human intestinal flora. This is particularly associated with a reduction in undesirable or pathogenic germs or an increase in desirable or non-pathogenic, particularly health-promoting, germs in the human intestine or in the human intestinal flora.

[0075] According to the invention, cineole, preferably 1,8-cineole, can also be used or employed to increase the diversity of microbes or to diversify the bacterial colonization of the human intestine, in particular the human intestinal flora. The increase in microbe diversity or diversification is particularly accompanied by an increase in the number of species of the underlying germs or bacteria, which equally include, in particular, health-promoting or non-pathogenic, preferably health-promoting, germs or bacteria.

[0076] According to the invention, cineole, preferably 1,8-cineole, can be used or employed in particular for reducing the germ load and / or the number of pathogenic germs in the human intestine and / or for reducing the proportion of pathogenic germs, based on the total number of germs in the human intestine, in particular in the human intestinal flora.

[0077] In this context, cineole, preferably 1,8-cineole, can also be used or employed in particular to increase the bacterial load or the number of germs or the proportion of germs, based on the total number of germs in the human intestine, of health-promoting or non-pathogenic, preferably health-promoting, germs, in particular as defined above, in the human intestine, in particular in the human intestinal flora.

[0078] As regards cineole, preferably 1,8-cineole, with regard to its use according to the invention, cineole, preferably 1,8-cineole, can equally be used or employed as an anti-inflammatory active ingredient, in particular as a systemically acting anti-inflammatory active ingredient.

[0079] In particular, cineole, preferably 1,8-cineole, can equally be used or employed as an active ingredient with anti-inflammatory effect on the peripheral blood in particular, preferably with anti-inflammatory effect on immune cells of the peripheral blood in particular.

[0080] With regard to the anti-inflammatory effect in question, according to the invention—without wishing to be limited to or relying on this theory—it may in particular be a somewhat indirect effect of cineole, preferably 1,8-cineole, namely insofar as it causes a reduction in the bacterial load of pathogenic germs and / or an increase in the colonization of the human intestine, particularly the intestinal flora, with health-promoting or non-pathogenic, preferably health-promoting, germs. This may be accompanied by an improvement in the condition of the intestinal epithelium, which is associated with corresponding anti-inflammatory effects, also at the systemic level. As previously stated, it may also generally be the case that excess cineole not consumed for the anti-dysbiotic effect is reabsorbed and additionally produces a systemic effect.

[0081] According to the invention, cineole, preferably 1,8-cineole, can equally be used to suppress or attenuate inflammatory mediation (ie inflammatory mediation or inflammatory cascade) occurring in the context of inflammatory diseases of the human body.

[0082] In particular, cineole, preferably 1,8-cineole, can exert a suppressive or attenuating effect on inflammatory mediation occurring in the context of inflammatory diseases of the human body.

[0083] Due to the so-called universal or cross-organ effect of cineole, preferably 1,8-cineole, in particular based on the reduction of pathogenic germs or the increase of health-promoting or non-pathogenic germs in the human intestine, in particular in the human intestinal flora, with the systemic effects in this regard, a large number of different inflammatory diseases can be reduced, avoided or cured according to the invention within the scope of the respective effect, since due to the underlying mechanisms there is so to speak a universal and, with regard to the specific underlying inflammatory disease, independent and thus generally valid principle of inflammation inhibition, namely in particular in connection with or as a result of the targeted influence on the human intestinal system based on the germs or bacteria present in the human intestine or in the human intestinal flora.

[0084] According to the invention, it can also be the case, in particular, that the inflammatory diseases of the human body are associated with the pathogenic germs in the human intestine, in particular in the human intestinal flora, or are caused, induced or aggravated thereby.

[0085] In particular, according to the invention, the inflammatory diseases of the human body can be associated with an excessive or abnormal or pathological colonization, in particular overpopulation, of the human intestine, in particular of the human intestinal flora, with the pathogenic germs or can be caused or induced or aggravated thereby.

[0086] In particular, the diseases may also be inflammatory diseases that are associated with dysbiosis or an incorrect colonization of the human intestine, in particular of the human intestinal flora, with pathogenic germs or are caused, induced and / or exacerbated by this.

[0087] According to the invention, the inflammatory diseases of the human body can also be acute inflammatory diseases or chronic inflammatory diseases. These are preferably chronic inflammatory diseases.

[0088] According to a particular embodiment of the present invention according to this aspect of the invention, it is particularly provided that the cineole, preferably 1,8-cineole, is administered systemically, in particular orally or parenterally, preferably orally. In this context, it can be provided in particular that the cineole, preferably 1,8-cineole, is prepared for systemic, in particular orally or parenterally, preferably orally, administration. In this way, high effective doses or active ingredient levels (i.e., active ingredient levels or concentrations) are achieved, particularly in the intestinal region, so that particularly good efficacy or efficiency can be realized.

[0089] In particular, the cineole, preferably 1,8-cineole, can be administered in the form of a dosage form to be administered orally and / or wherein the cineole, preferably 1,8-cineole, can be prepared in a dosage form to be administered orally.

[0090] According to a further particular embodiment of the present invention according to this aspect, it can also be provided in this context that the cineole, preferably 1,8-cineole, is administered as an enteric-coated but small intestine-soluble systemic dosage form, preferably as a capsule, coated tablet, pill, tablet, or the like. In particular, the cineole, preferably 1,8-cineole, can be prepared for administration as an enteric-coated but small intestine-soluble systemic dosage form, preferably as a capsule, coated tablet, pill, tablet, or the like. Due to the enteric-coated or small intestine-soluble systemic dosage form, the effective dose or the active ingredient level in the intestinal region can be further increased due to the targeted release "on site."In general, within the scope of the present invention, it is therefore intended that the oral dosage form, particularly in the form of a capsule, be enteric-coated but soluble in the small intestine. This achieves a particularly optimal release profile, since the active ingredient is released in a targeted and effective manner only in the intestine.

[0091] The definitions of the terms "gastric-resistant" and "small intestine-soluble" used in the present invention, as well as the corresponding test methods, are reproduced in European Pharmacopoeia 7.0, 04 / 2010: 1502, pages 707 to 709, keyword "Capsules", subchapter "Gastro-Resistant Capsules" and European Pharmacopoeia 7.1, 04 / 2011: 20901, pages 3331 and 3332, keyword "2.9.1 Disintegration of Tablets and Capsules".

[0092] In the context of the present invention, the term “enteric coating resistant” is to be understood in particular as meaning that the capsules can be stored, in particular stirred, for at least two hours in 0.1 N hydrochloric acid, which is heated to temperatures of 35 to 39 °C, with constant mixing, without the capsules showing signs of decomposition, cracks or other damage.

[0093] In the context of the present invention, the term “small intestine soluble” is to be understood in particular as meaning that the capsules are dissolved in an aqueous phosphate buffer solution, which is adjusted to a pH of approximately 6.8, while stirring at temperatures in the range of 35 to 39 °C within one hour to such an extent that the active substance is released.

[0094] For the use of cineole, especially 1,8-cineole, various preparations are available on the market, especially based on generally gastro-resistant but small intestine-soluble dosage forms or capsules (e.g. Soledum ® -Capsules or Soledum ® forte capsules, distributed by Cassella-med GmbH & Co. KG or Maria Clementine Martin Klosterfrau Vertriebsgesellschaft mbH, both Cologne, Germany).

[0095] According to the invention, it can be provided that the cineole, preferably 1,8-cineole, is administered in pharmaceutically effective or therapeutically effective amounts and / or that the cineole, preferably 1,8-cineole, is prepared for administration in pharmaceutically effective or therapeutically effective amounts.

[0096] Within the scope of the present invention, it is particularly provided that the cineole, preferably 1,8-cineole, is administered with a daily dose in the range of 1 to 5,000 mg / diem, in particular in the range of 2 to 3,000 mg / diem, preferably in the range of 5 to 2,500 mg / diem, preferably in the range of 10 to 2,000 mg / diem, particularly preferably in the range of 50 to 1,500 mg / diem, and / or wherein the cineole, preferably 1,8-cineole, is administered with a daily dose in the range of 1 to 5,000 mg / diem, in particular in the range of 2 to 3,000 mg / diem, preferably in the range of 5 to 2,500 mg / diem, preferably in the range of 10 to 2,000 mg / diem, particularly preferably in the range of 50 to 1,500 mg / diem, is prepared.

[0097] In particular, within the scope of the present invention and according to this aspect of the invention, according to a particular embodiment, it can also be provided that the cineole, preferably 1,8-cineole, is present or administered as a pure substance. In this context, the cineole, preferably 1,8-cineole, can be present or administered with a purity of at least 95% by weight, in particular at least 96% by weight, preferably at least 97% by weight, particularly preferably at least 98% by weight, very particularly preferably at least 99% by weight, even more preferably at least 99.5% by weight, based on the cineole, preferably 1,8-cineole. In particular, it can also be provided in this context that the cineole, preferably 1,8-cineole, is free of other terpenes or that the cineole, preferably 1,8-cineole, does not contain any other terpenes.

[0098] As described above, it is therefore preferred according to the invention that the monoterpene-based active substance (i.e. cineole, preferably 1,8-cineole) is used in the form of a pure substance, i.e. as the sole or technically isolated / purified active ingredient or free from other terpenes. In this way, for example, a consistently constant dosage or a consistent content of active substance can be ensured in the dosage form provided according to the invention. In particular, high active substance doses or levels can be achieved in this way, even at the site of action. As a result of the preferred use according to the invention of cineole, in particular 1,8-cineole, in pure form or free from other terpenes, a particularly defined action profile with regard to the underlying indication is also ensured. As previously stated, administration in pure form also provides a defined steroid-like action profile.

[0099] According to yet another embodiment of the present invention, it can be provided that the cineole, preferably 1,8-cineole, is present or administered together with at least one physiologically acceptable carrier (excipient).

[0100] In particular, it may be provided that the physiologically acceptable carrier (excipient) is miscible with cineole or 1,8-cineole and / or soluble therein.

[0101] In particular, the physiologically acceptable carrier (excipient) can be in the liquid or solid, preferably liquid, state at 20 °C and at atmospheric pressure.

[0102] In this context, it may further be provided that the physiologically acceptable carrier (excipient) is selected from the group of fatty acid esters, preferably triglycerides of fatty acids, particularly preferably medium-chain triglycerides (Medium Chain Triglycerides or MCT), very particularly preferably triglycerides of C6-C 12 -fatty acids.

[0103] Specifically medium-chain triglycerides, as they are preferably used according to the invention as carriers or excipients for the monoterpene-containing active substance, are in particular semi-synthetic neutral glycerol esters of saturated, generally unbranched monocarboxylic acids of medium chain length (ie C6-C 12-chains). In particular, the term medium-chain triglycerides refers to mixtures of triglycerides of saturated fatty acids, mainly caprylic acid (octanoic acid) and capric acid (decanoic acid). Medium-chain triglycerides can generally be produced from oil extracted from the solid and dried part of the endosperm of Cocos nucifera L. and / or from the dried endosperm of Elaeis guineenses Jacq. For further details on the term medium-chain triglycerides, reference can be made, for example, to the monograph Ph. Eur., 6th edition, Grundwerk 2008, pages 4224 to 4226, as well as to the Zeitschrift für Ernährungswissenschaft, Volume 13, Issue 1 / 2, 1973, pages 6 ff., D. Sailer et al. "Medium-chain triglycerides - Clinical physiology and application").

[0104] According to the invention, it is preferred if the carrier or excipient is used in an active substance / carrier ratio in the range from 1,000:1 to 1:1,000, in particular 100:1 to 1:100, preferably 50:1 to 1:50, particularly preferably 10:1 to 1:10, very particularly preferably 5:1 to 1:2, even more preferably 3:1 to 1:1. By mixing the active substance (ie cineole, in particular 1,8-cineole) with the excipient, a significantly improved compatibility of the active substance with the other ingredients of the dosage form and improved stability, in particular storage stability, are achieved.

[0105] According to an equally further particular embodiment of the present invention, it can be provided that the cineole, preferably 1,8-cineole, is present and / or administered in or in the form of a composition, in particular a pharmaceutical composition, in particular together with at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier).

[0106] In this context, it may in particular be provided that the composition contains cineole, preferably 1,8-cineole, as the sole active ingredient, in particular as the sole pharmaceutical active ingredient.

[0107] Furthermore, it can be provided in particular that the composition contains the cineole, preferably 1,8-cineole, as a pure substance, preferably with a purity of at least 95% by weight, in particular at least 96% by weight, preferably at least 97% by weight, particularly preferably at least 98% by weight, very particularly preferably at least 99% by weight, even more preferably at least 99.5% by weight, based on the cineole, preferably 1,8-cineole, and / or preferably free from other terpenes.

[0108] Likewise, it can also be provided that the composition contains the cineole, preferably 1,8-cineole, at least substantially free of other terpenes and / or in particular wherein the composition contains at least substantially no further terpene and / or in particular wherein the composition is at least substantially free of terpenes other than cineole, preferably 1,8-cineole.

[0109] Furthermore, it can be provided that the composition contains cineole, preferably 1,8-cineole, in effective, in particular pharmaceutically and / or therapeutically effective, amounts.

[0110] Likewise, in this context, it may be provided according to the invention that the composition contains the cineole, preferably 1,8-cineole, based on the composition, in relative amounts in the range from 0.0001 to 80 wt.%, in particular 0.001 to 75 wt.%, preferably 0.005 to 70 wt.%, preferably 0.01 to 60 wt.%, particularly preferably 0.05 to 55 wt.%, very particularly preferably 0.1 to 50 wt.%.

[0111] Finally, in this context, it can also be provided according to the invention that the at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier) is miscible with cineole or 1,8-cineole and / or soluble therein, preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier) is present at 20 °C and at atmospheric pressure in the liquid or solid, preferably liquid, state of aggregation and / or preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier) is selected from the group of fatty acid esters, preferably triglycerides of fatty acids, particularly preferably medium-chain triglycerides (Medium Chain Triglycerides or MCT), very particularly preferably triglycerides of C6-C 12 -fatty acids.

[0112] According to a particular embodiment of the present invention, the cineole, preferably 1,8-cineole, can be present and / or administered in liposome-enclosed and / or liposomally packaged form. This ensures a particularly good release profile.

[0113] According to a further particular embodiment of the present invention, the cineole, preferably 1,8-cineole, can be present or administered in micellized form or in a micellar dosage form.

[0114] According to the invention, it can further be provided that the cineole, preferably 1,8-cineole, is present or administered as a single active ingredient or as a monopreparation.

[0115] According to the invention, it can be provided in this context that the cineole, preferably 1,8-cineole, is present or administered without or in the absence of further active substances other than cineole, preferably 1,8-cineole.

[0116] In contrast, according to the invention, it can also be provided that the cineole, preferably 1,8-cineole, is present or administered together with at least one other active ingredient and / or as a co-therapeutic agent.

[0117] In this context, it can be provided, in particular, that the further active ingredient is selected from (i) anti-inflammatory agents (anti-inflammatories), in particular non-steroidal anti-inflammatory drugs (NSAIDs) or steroidal anti-inflammatories, preferably steroidal anti-inflammatories, preferably corticosteroids; (ii) antibiotics, (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; as well as combinations thereof.

[0118] According to a particularly preferred embodiment, it can be provided in particular that the further active ingredient is used or administered separately, in particular spatially separated, from the cineole, preferably 1,8-cineole, but functionally connected thereto, in particular in the form of a kit (kit-of-part).

[0119] In the aforementioned manner (i.e. combination or joint administration with at least one other active ingredient), the effect or efficacy of the other active ingredient can be increased. At the same time, the interaction can also significantly increase sensitivity to the other active ingredient, as is the case, for example, with anti-inflammatory agents. Likewise, the efficacy can be improved, for example, through combined administration with prebiotics or microorganisms that have a positive effect on the intestinal flora, as this can further influence or build up the intestinal flora, specifically with a view to preferential treatment of non-pathogenic or health-promoting germs or with a view to a further targeted reduction of pathogenic germs (as can generally also be the case, for example, with the preferential use of specific antibiotics).

[0120] In particular, the cineole, preferably 1,8-cineole, can be present or administered together with at least one prebiotic. In this context, the prebiotic can be a substance that specifically promotes the growth of microorganisms that positively influence the intestinal flora. In this context, it can also be selected from the group of, in particular, natural polysaccharides, especially natural oligosaccharides, and sugar alcohols.

[0121] In particular, the prebiotic can be gum arabic.

[0122] Likewise, in this context, the prebiotic can be selected from the group of fructooligosaccharides and galactooligosaccharides, in particular in the form of tri- to pentasaccharides, and combinations thereof. In particular, the prebiotic can be selected from the group of inulin, sucrose, stachyose, raffinose, lactulose, and combinations thereof.

[0123] Furthermore, within the scope of the present invention, it can be provided that the cineole, preferably 1,8-cineole, is present or administered together with microorganisms that positively influence the intestinal flora. These can, in particular, be health-promoting or non-pathogenic microorganisms as such. For example, the microorganisms can be selected from the group of yeasts and bacteria. In this context, it can, in particular, be provided according to the invention that the microorganisms are selected from the group of species of the genus Saccharomyces, in particular Saccharomyces boulardii and Saccharomyces cervesiae, preferably Saccharomyces boulardii, as well as combinations thereof.Likewise, in this context, it can be provided according to the invention that the microorganisms are selected from the group of species of the genus Bifidobacterium, Lactobacillus, Enterococcus, Escherichia, Streptococcus, in particular in the form of their species which positively influence the intestinal flora, and combinations thereof.

[0124] In general, the microorganisms can be presented or administered as a dry substance, especially as a biologically active dry substance, particularly in lyophilized form and / or as a lyophilisate. This is particularly beneficial for handling while maintaining high efficacy.

[0125] The present invention also relates, according to the present aspect, to cineole, preferably 1,8-cineole, in particular cineole for use as defined above, for use in the prophylactic or therapeutic treatment of dysbiosis or of incorrect colonization of the human intestine, in particular of the human intestinal flora, with pathogenic germs.

[0126] In particular, in the context of the treatment of dysbiosis or incorrect colonization of the human intestine, in particular of the human intestinal flora, with pathogenic germs, a regeneration and / or rehabilitation of the microbiome of the human intestine, in particular of the human intestinal flora, can be carried out.

[0127] In this regard, optimization or regeneration of the intestinal flora can also be achieved within the scope of the present invention, particularly against the background of or for the purposes of preventing, reducing, or curing inflammatory diseases of the human body, or in particular for the purposes of the prophylactic and / or therapeutic treatment of inflammatory diseases of the human body. In this context, cineole, in particular 1,8-cineole, also has an antidysbiotic effect. Consequently, cineole, in particular 1,8-cineole, can also function as an antidysbiotic in this regard.

[0128] The present invention, both according to the first aspect of the present invention and according to all other aspects of the present invention, is thus associated with a multitude of advantages and special features which make the therapeutic concept according to the invention unique and special, in particular highly effective, and this with, at the same time, good tolerability and easy application of the active substance present or used according to the invention.

[0129] For further details on this aspect of the invention, reference can also be made to the following statements on the other aspects of the invention, which statements apply equally to the present aspect of the invention.

[0130] A further subject matter of the present invention - according to a second aspect of the present invention - is also the inventive use of cineole for reducing pathogenic germs in the human intestine and for reducing the colonization of the human intestine with pathogenic germs and equally for increasing the colonization of the human intestine with health-promoting or non-pathogenic germs.

[0131] Within the scope of the use according to this aspect of the invention, it is particularly provided that the active ingredient or cineole, preferably 1,8-cineole, is administered orally, in particular in the form of a gastric juice-resistant but small intestine-soluble dosage form or composition.

[0132] Likewise, according to the present aspect, the present invention also relates to the use of cineole, preferably 1,8-cineole, in particular a use as defined herein (for the manufacture of a medicament) for the prophylactic and / or therapeutic treatment of dysbiosis and / or of incorrect colonization of the human intestine, in particular of the human intestinal flora, with pathogenic germs.

[0133] In this regard, the cineole, preferably 1,8-cineole, in particular the drug or medicament can be administered in pharmaceutically effective or therapeutically effective amounts.

[0134] In particular, the cineole, preferably 1,8-cineole, in particular the medicament or drug can be prepared for administration in pharmaceutically effective or therapeutically effective amounts.

[0135] In addition, the cineole, preferably 1,8-cineole, in particular the drug or medicament, can be administered systemically.

[0136] According to the invention, in this context, the cineole, preferably 1,8-cineole, in particular the pharmaceutical or medicament or the composition, can be used or applied together with at least one further active ingredient, in particular wherein the further active ingredient is selected from the group of (i) anti-inflammatory agents (anti-inflammatories), in particular non-steroidal anti-inflammatories (NSAIDs) or steroidal anti-inflammatories, preferably steroidal anti-inflammatories, preferably corticosteroids; (ii) antibiotics, (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; and combinations thereof.

[0137] For further details on this aspect of the invention, reference can be made to the statements on the other aspects of the invention, which statements apply equally to the present aspect of the invention.

[0138] The present invention also relates - according to a third aspect of the present invention - to the pharmaceutical or medicament for use in reducing pathogenic germs in the human intestine and for reducing the colonization of the human intestine with pathogenic germs and equally for use in increasing the colonization of the human intestine with health-promoting or non-pathogenic germs, wherein the pharmaceutical or medicament contains cineole together with at least one pharmaceutically acceptable and / or physiologically acceptable carrier.

[0139] According to this aspect, the present invention relates to the pharmaceutical composition or medicament according to the invention, in particular intestinal treatment agent, in particular as defined above, for the prophylactic and / or therapeutic treatment of dysbiosis and / or of incorrect colonization of the human intestine, in particular of the human intestinal flora, with pathogenic germs, wherein the pharmaceutical composition or medicament, in particular intestinal treatment agent, contains cineole, preferably 1,8-cineole, together with at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier).

[0140] In this regard, it can be provided according to the invention that the medicament or drug contains cineole, preferably 1,8-cineole, as the sole active ingredient, in particular as the sole pharmaceutical active ingredient.

[0141] According to the invention, it can also be provided that the pharmaceutical or medicament contains the cineole, preferably 1,8-cineole, as a pure substance, preferably with a purity of at least 95% by weight, in particular at least 96% by weight, preferably at least 97% by weight, particularly preferably at least 98% by weight, very particularly preferably at least 99% by weight, even more preferably at least 99.5% by weight, based on the cineole, preferably 1,8-cineole, and / or preferably free from other terpenes.

[0142] In particular, the medicinal product or drug may contain cineole, preferably 1,8-cineole, free from other terpenes. In particular, the medicinal product or drug may not contain any other terpenes. In particular, the medicinal product or drug may be free from terpenes other than cineole, preferably 1,8-cineole.

[0143] According to the invention, the medicament or drug may contain cineole, preferably 1,8-cineole, in effective, in particular pharmaceutically and / or therapeutically effective, amounts.

[0144] In particular, it can be provided that the medicament or drug according to the invention contains the cineole, preferably 1,8-cineole, based on the medicament or drug, in relative amounts in the range from 0.0001 to 80 wt.%, in particular 0.001 to 75 wt.%, preferably 0.005 to 70 wt.%, preferably 0.01 to 60 wt.%, particularly preferably 0.05 to 55 wt.%, very particularly preferably 0.1 to 50 wt.%.

[0145] According to yet another particular embodiment according to this aspect of the invention, it can also be provided that the at least one pharmaceutically acceptable or physiologically acceptable excipient (carrier) is miscible with cineole or 1,8-cineole and / or soluble therein, preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier) is present at 20°C and at atmospheric pressure in the liquid or solid, preferably liquid, state of aggregation and / or preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier) is selected from the group of fatty acid esters, preferably triglycerides of fatty acids, particularly preferably medium-chain triglycerides (Medium Chain Triglycerides or MCT), very particularly preferably triglycerides of C6-C 12 -fatty acids.

[0146] In this regard, the cineole, preferably 1,8-cineole, in particular the drug or medicament, can be administered in pharmaceutically effective or therapeutically effective amounts.

[0147] In particular, the cineole, preferably 1,8-cineole, in particular the drug or medicament, can be prepared for administration in pharmaceutically effective or therapeutically effective amounts.

[0148] In addition, the cineole, preferably 1,8-cineole, in particular the drug or medicament, can be administered systemically.

[0149] According to the invention, in this context, the cineole, preferably 1,8-cineole, in particular the pharmaceutical or medicament, or the composition, can be used or applied together with at least one further active ingredient, in particular wherein the further active ingredient is selected from the group of (i) anti-inflammatory agents (anti-inflammatories), in particular non-steroidal anti-inflammatories (NSAIDs) or steroidal anti-inflammatories, preferably steroidal anti-inflammatories, preferably corticosteroids; (ii) antibiotics, (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; and combinations thereof.

[0150] For further details on this aspect of the invention, reference can be made to the above statements on the other aspects of the invention, which statements apply equally to the present aspect of the invention.

[0151] Yet another subject of the present invention - according to a fourth aspect of the present invention - is also the pharmaceutical composition for use in reducing pathogenic germs in the human intestine and for use in reducing the colonization of the human intestine with pathogenic germs and equally for use in increasing the colonization of the human intestine with health-promoting or non-pathogenic germs, wherein the composition contains cineole, in particular together with at least one pharmaceutically acceptable and / or physiologically acceptable carrier.

[0152] In this context, the present invention according to this aspect also relates to the pharmaceutical composition, in particular as defined above, for (use in the) prophylactic and / or therapeutic treatment of dysbiosis and / or of colonization of the human intestine, in particular of the human intestinal flora, with pathogenic germs, wherein the composition contains cineole, preferably 1,8-cineole, in particular together with at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier).

[0153] The composition may contain cineole, preferably 1,8-cineole, as the sole active ingredient, in particular as the sole pharmaceutical active ingredient.

[0154] In addition, the composition can contain the cineole, preferably 1,8-cineole, as a pure substance, preferably with a purity of at least 95% by weight, in particular at least 96% by weight, preferably at least 97% by weight, particularly preferably at least 98% by weight, very particularly preferably at least 99% by weight, even more preferably at least 99.5% by weight, based on the cineole, preferably 1,8-cineole, and / or preferably free from other terpenes.

[0155] The composition according to the invention may contain cineole, preferably 1,8-cineole, free from other terpenes.

[0156] In particular, the composition may not contain any other terpene. Likewise, the composition may be free of terpenes other than cineole, preferably 1,8-cineole.

[0157] According to the invention, it is particularly provided that the composition contains cineole, preferably 1,8-cineole, in effective, in particular pharmaceutically and / or therapeutically effective, amounts.

[0158] In this regard, the composition may contain the cineole, preferably 1,8-cineole, based on the composition, in relative amounts in the range of 0.0001 to 80 wt.%, in particular 0.001 to 75 wt.%, preferably 0.005 to 70 wt.%, preferably 0.01 to 60 wt.%, particularly preferably 0.05 to 55 wt.%, most particularly preferably 0.1 to 50 wt.%.

[0159] In particular, the at least one pharmaceutically acceptable or physiologically acceptable excipient (carrier) can be miscible with cineole or 1,8-cineole and / or soluble therein, preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier) is in the liquid or solid, preferably liquid, state of aggregation at 20 °C and at atmospheric pressure.

[0160] In this regard, the at least one pharmaceutically acceptable and / or physiologically acceptable excipient (carrier) can be selected from the group of fatty acid esters, preferably triglycerides of fatty acids, particularly preferably medium-chain triglycerides (Medium Chain Triglycerides or MCT), very particularly preferably triglycerides of C6-C 12 -fatty acids.

[0161] In particular, the cineole, preferably 1,8-cineole, in particular the composition, can be administered in pharmaceutically effective or therapeutically effective amounts. In particular, the cineole, preferably 1,8-cineole, in particular the composition, can be prepared for administration in pharmaceutically effective or therapeutically effective amounts. In particular, the cineole, preferably 1,8-cineole, in particular the pharmaceutical or medicament or the composition, can be administered systemically.

[0162] In this regard, the cineole, preferably 1,8-cineole, in particular the composition, can also be used or applied together with at least one further active ingredient, in particular wherein the further active ingredient is selected from the group of (i) anti-inflammatory agents (anti-inflammatories), in particular non-steroidal anti-inflammatories (NSAIDs) or steroidal anti-inflammatories, preferably steroidal anti-inflammatories, preferably corticosteroids; (ii) antibiotics, (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; and combinations thereof.

[0163] For further details on this aspect of the invention, reference can be made to the statements on the other aspects of the invention, which statements apply equally to the present aspect of the invention.

[0164] Finally, the subject of the present invention - according to a fifth aspect - of the present invention - is equally the pharmaceutical combination for use in reducing pathogenic germs in the human intestine and for use in reducing the colonization of the human intestine with pathogenic germs, and equally for use in increasing the colonization of the human intestine with health-promoting or non-pathogenic germs, wherein the pharmaceutical combination comprises at least the following components (A) and (B): (A) Cineole; and (B) at least one further active ingredient selected from the group of (i) anti-inflammatory agents, in particular non-steroidal anti-inflammatory agents or steroidal anti-inflammatory agents, preferably steroidal anti-inflammatory agents, preferably corticosteroids; (ii) antibiotics, (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; and combinations thereof.

[0165] According to the present aspect, the present invention also relates to the pharmaceutical combination, in particular a pharmaceutical combination as defined above, for use in the prophylactic and / or therapeutic treatment of dysbiosis and / or of colonization of the human intestine, in particular of the human intestinal flora, with pathogenic germs, wherein the pharmaceutical combination comprises at least the following components (A) and (B): (A) Cineole, preferably 1,8-cineole; and (B) at least one further active ingredient selected from the group of (i) anti-inflammatory agents (anti-inflammatories), in particular non-steroidal anti-inflammatory drugs (NSAIDs) or steroidal anti-inflammatories, preferably steroidal anti-inflammatories, preferably corticosteroids; (ii) antibiotics, (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; and combinations thereof.

[0166] Within the scope of this aspect of the invention, it is also specifically provided that the active ingredient of component (A) or the cineole, preferably 1,8-cineole, is administered in pharmaceutically effective or therapeutically effective amounts, or that the cineole, preferably 1,8-cineole, is prepared for administration in pharmaceutically effective or therapeutically effective amounts. This also applies accordingly to the active ingredient according to component (B).

[0167] In particular, the active ingredient of component (A) or cineole, preferably 1,8-cineole, can be administered systemically. The other active ingredient of component (B) can also be applied systemically.

[0168] According to a particular embodiment of this aspect of the invention, it can be provided in particular that components (A) and (B) are present and / or administered separately from one another, in particular spatially separated from one another, but functionally connected and / or functionally associated with one another.

[0169] Furthermore, according to a particular embodiment of this aspect of the invention, it can be provided in particular that the pharmaceutical combination is in the form of a kit (kit of parts), in particular as a kit of components (A) and (B).

[0170] In particular, components (A) and (B) can be presented or prepared or administered as a kit (kit of parts).

[0171] In the context of the present invention, a kit or kit-of-parts is understood to mean in particular a unit or arrangement or compilation or combination of the two components (A) and (B), in which the two components (A) and (B) are present separately and / or separately, in particular spatially separated and / or spatially separated, but are provided or administered as functionally related or functionally associated components.

[0172] For further details on this aspect of the invention, reference can be made to the statements on the other aspects of the invention, which statements apply equally to the present aspect of the invention.

[0173] Further advantageous properties, aspects, and features of the present invention will become apparent from the following description of exemplary embodiments illustrated in the figures, as detailed below. It shows: Fig. Figure 1 shows a graphic representation of a principal coordinate analysis (PCoA) of stool samples from five patients (1-5) with nasal polyposis, before (unmarked, open circle symbols) and after 2 weeks of taking 1,8-cineole (marked with "*", filled circle symbols); Fig. Figure 2 shows a graphical representation in bar chart form of the effect of 1,8-cineole on the intestinal microbiome or intestinal flora of patients with nasal polyposis. The x-axis indicates the status or composition of the intestinal microbiome before cineole administration, and the x-axis indicates the status or composition of the intestinal microbiome after 2 weeks of cineole administration. The y-axis indicates the number of sequencing reads performed. Fig. 3A / B a respective graphic representation in the form of bar charts, showing that the intake of 1,8-cineole causes a significant decrease in the cellular complexes of various leukocytes [with "Lymphos" = lymphocytes; "Monos" = monocytes; "Neutros" = neutrophils; "Eosinos" = eosinophils in the blood of patients with nasal polyposis; the situation is shown in each case before ("before") and after 2 weeks of administration of 1,8-cineole ("after"); Fig. 3A refers to the data n1, and Fig. 3B refers to the data n2, see also the following explanations)]; Fig. 4A / B / C a respective graphic representation based on pie charts, which overall show the reduction in the population of so-called “classical” monocytes and a significant increase in so-called “intermediate” monocytes in the blood of patients examined with nasal polyposis ( Fig. 4B) compared to healthy donors ( Fig. 4A), which also shows that after taking 1,8-cineole over a period of two weeks, there is a clear reversal in the distribution of the respective monocytes ( Fig. 4C), which is comparable to the distribution pattern of healthy donors; in this context, the pie chart according to Fig. 4A thus the situation for healthy donors, the pie chart according to Fig. 4B thus shows the situation for patients with nasal polyposis and the pie chart according to Fig. 4C the situation for patients with nasal polyposis after taking 1,8-cineole for a period of two weeks (with a = “non-classical” monocytes, b = “intermediate” monocytes and c = “classical” monocytes); Fig. Figures 5A and B show a graphical representation of monocyte distribution under the influence of a 2-week treatment with 1,8-cineole and before and after 2 weeks of treatment with 1,8-cineole, respectively. The studies demonstrate a strong response to the administration of 1,8-cineole, with a significant increase in CD16 "classical" monocytes ("CD16 neg."; Fig. 5A") and at the same time a significant decrease in "intermediate" monocytes ("CD16 pos."; Fig. 5B") after treatment with 1,8-cineole shows [in Fig. 5A / B, the respective left circle representation shows the situation before the cineole treatment and the respective right box representation shows the situation after the cineole therapy.

[0174] For further details on the embodiments and exemplary embodiments shown in the figures, in order to avoid unnecessary repetition, reference can be made to the above statements and to the following supplementary statements on the exemplary embodiments, which apply accordingly with regard to the figures.

[0175] Further embodiments, modifications and variations as well as advantages of the present invention will be readily apparent and achievable to a person skilled in the art upon reading the description, without departing from the scope of the present invention.

[0176] The following embodiments serve only to illustrate the present invention, without, however, limiting the present invention thereto. EXAMPLES:Example 1: Anti-inflammatory effect of 1,8-cineole on the intestinal microbiome as well as anti-dysbiotic or anti-pathogenic effect of 1,8-cineole on pathogenic intestinal bacteria

[0177] The human microbiome, especially the intestinal microbiome, has a fundamental regulatory influence on inflammatory processes and the associated immune regulation.

[0178] In the present case, it can be shown that a direct local influence of 1,8-cineole, which is administered as a small intestinal permeable or soluble preparation (Soledum ® forte, cineole content: 200 mg), on the intestinal microbiome, with far-reaching effects on systemic and local inflammatory processes in the human body also being observed.

[0179] In the study, stool samples from patients with nasal polyposis under the influence of 1,8-cineole are analyzed. For this purpose, a stool sample is taken first before the start of 1,8-cineole administration and then again after 2 weeks of taking 1,8-cineole 3 times daily (Soledum ® forte, 1,8-cineole content: 200 mg).

[0180] Stool samples are treated with Stool Stabilizer (Stratec Molecular) and initially stored at -20°C until further processing. Subsequent DNA extraction is performed using the PSP Spin Stool DNA Plus kit according to the manufacturer's instructions (Stratec Molecular). The isolated DNA is then used for microbiome sequencing (TG MiSeq Reagent Kit v3 & NEBNext). ® Library Quant Kit for Illumina) was used and evaluated.

[0181] The results are in Fig. 1, in the form of a principal coordinate analysis (PCoA) of the stool samples examined from patients (1 to 5) with nasal polyposis before (unmarked, open circle symbols) and after 2 weeks of taking 1,8-cineole (marked with "*", filled circle symbols).

[0182] The studies show a significant shift in the so-called beta diversity in the analyzed patient samples based on the principal coordinate analysis (PCoA), i.e. the heterogeneity or, so to speak, the dissimilarity of the measured samples before and after the intake of 1,8-cineole, which means that a corresponding change occurs under the influence of 1,8-cineole.

[0183] Following this initial evaluation of existing alterations or changes in the intestinal microbiome of patients with nasal polyposis after 2 weeks of taking 1,8-cineole, a detailed evaluation of the microbiome sequencing performed will be carried out with regard to the identified bacterial genera.

[0184] The relevant studies show a significant shift in the composition of the intestinal microbiome of patients with nasal polyposis after 2 weeks of taking 1,8-cineole. Fig. Figure 2 illustrates the influence of 1,8-cineole on the intestinal microbiome of patients with nasal polyposis (where “a” refers to the situation or composition of the intestinal microbiome before administration of cineole and “b” refers to the situation after 2 weeks of cineole intake; furthermore, the Y-axis shows the number of sequencing reads performed).

[0185] In this context, Fig. 2 thus the significant shifts of various bacterial genera discovered according to the invention: In particular, the analyses of the microbiome show that the bacterial genus Prevotella is very prominent as a pathogenic or pro-inflammatory germ in the intestine of the examined patients with nasal polyposis and is significantly reduced after 2 weeks of taking 1,8-cineole, with an almost complete disappearance being observed in this regard.

[0186] The genus Prevotella generally includes about forty different species, which often cause various inflammatory processes of the oral cavity (Prevotella bivia, Prevotella disiens) or the respiratory tract (Prevotella melaninogenica, Prevotella intermedia).

[0187] In addition, a significant change in the occurrence of germs, for example in the very common genus Bacteroides, which is non-pathogenic and particularly health-promoting and has overall positive effects for humans, can be observed, namely in that these are significantly more common after therapy with 1,8-cineole. In other families or genera belonging to the normal human intestinal flora, such as Lachnospiraceae, Bifidobacterium or Faecalibacterium, certain changes or shifts with a tendency towards an increase can also be observed after therapy.

[0188] Further analyses of the microbiome sequencing studies conducted also led to the identification of a significant increase in bacteria of the Ruminococcacea family or the Ruminococcus genus following the intake of 1,8-cineole, with such bacteria being known to produce anti-inflammatory short-chain fatty acids, such as butyrate.

[0189] The studies thus demonstrate the positive effects of 1,8-cineole on the composition of the human intestinal microbiome or intestinal flora, with a reduction in inflammatory or negative germs and an increase in anti-inflammatory or positive germs, which is also associated with an influence on whole-body or systemic inflammatory processes. Example 2: Anti-inflammatory effect of 1,8-cineole on immune cells in peripheral blood

[0190] As explained above, 1,8-cineole exerts a positive effect on the intestinal epithelium and the immune cells present there at its primary site of action, namely the human intestine. This is particularly based on the reduction of pathogenic germs in the human intestinal microbiome, thus reducing or preventing their negative influence on the intestinal epithelium (see previous example). This, in turn, leads to an improvement in the relevant immune status (i.e., induction of active or primary anti-inflammatory mediation). This is documented by the following experiment.

[0191] The present study describes the regulation of circulating blood cells / immune cells in patients with nasal polyposis under the influence of 1,8-cineole.

[0192] Fluorescence microscopy analyses show a significant increase in the complex formation of circulating platelets (CD41) with different immune cells (DAPI) in patients with nasal polyposis and also indicate a resulting regulation of immune functions, such as the expression levels of the cytokine TNFα.

[0193] Furthermore, these cellular complexes are further specified using flow cytometry with regard to different leukocyte populations and the influence of 1,8-cineole.

[0194] It is shown that these cellular complexes occur in the blood of patients with nasal polyposis, particularly in connection with monocytes, and that after taking 1,8-cineole (see above) over a period of two weeks, a massive reduction in these monocyte complexes can be observed, as can be seen from the following tables and in Fig. 3A / 3B [with “Lymphos” = lymphocytes; “Monos” = monocytes; “Neutros” = neutrophils; “Eosinos” = eosinophils in the blood of patients with nasal polyposis; the situation is shown before (“before”) and after 2 weeks of administration of 1,8-cineole (“after”); Fig. 3A refers to the data n1 according to Table 1, and Fig. 3B refers to the data n2 according to Table 2). Table 1: n1 vorher nachher Lymphos 12,4 % 5,54 % Monos 14,7 % 8,79 % Neutros 13,9 % 5,02 % Eosinos 7,3 % 5,92 % Table 2: n1 vorher nachher Lymphos 5,4 % 5,12 % Monos 16,8 % 6,28 % Neutros 5,37 % 5,09 % Eosinos 10,7 % 4,8 %

[0195] The monocytes circulating in the blood can be divided into three different subtypes based on their surface proteins CD14 and CD16 using flow cytometry: "classical," "intermediate," and "non-classical." In flow cytometry, the cells are analyzed for cell size, granularity, and the fluorescent labeling of specific epitopes by passing them through specific lasers. This allows different cell populations to be differentiated and characterized. While "classical" monocytes differentiate into anti-inflammatory macrophages after migrating into inflammatory tissue, "non-classical" monocytes develop into immunosuppressive macrophages, which do not suppress the inflammatory processes and thus perpetuate the associated clinical picture.

[0196] The studies show a reduction in the population of “classical” monocytes and a significant increase in the population of “intermediate” monocytes in the blood of the examined patients with nasal polyposis compared to healthy donors, thus indicating a possibly increased infiltration of the inflammatory polyp tissue by immunosuppressive macrophages and a resulting persistent inflammatory progression of the nasal polyps. This may also be due to Fig. 4 A / B / C.

[0197] In this context, Fig. 4 A / B / C the found reduction in the population of “classical” monocytes and the significant increase in “intermediate” monocytes in the blood of the examined patients with nasal polyposis compared to healthy donors.

[0198] After 2 weeks of taking 1,8-cineole, the monocyte populations in the blood of patients with nasal polyposis are again examined using a flow cytometer and a clear normalization or reversal of the distribution of the monocyte subpopulations is observed, comparable to the distribution pattern in healthy individuals or donors.

[0199] Fig. 4 A / B / C shows the overall reduction of the population of “classical” monocytes and a significant increase of “intermediate” monocytes in the blood of patients with nasal polyposis ( Fig. 4B) compared to healthy donors ( Fig. 4A). In addition, it is shown that after taking 1,8-cineole over a period of two weeks, a significant normalization or reversal of the distribution of the respective monocytes results ( Fig. 4C), which is comparable to the distribution pattern of healthy donors. The pie chart according to Fig. 4A shows the situation for healthy donors, the pie chart according to Fig. 4B the situation for patients with nasal polyposis and the pie chart according to Fig. 4C shows the situation for patients with nasal polyposis after treatment or intake of 1,8-cineole for a period of two weeks (with a = “non-classical” monocytes, b = “intermediate” monocytes and c = “classical” monocytes).

[0200] These observations are now being comprehensively analyzed in additional patients individually using flow cytometry, particularly under the influence of 1,8-cineole. The studies confirm a strong response of circulating immune cells to the intake of 1,8-cineole in the patients studied, accompanied by a restoration of monocyte distribution comparable to the healthy situation. This can also be attributed to Fig. 5A / B.

[0201] Fig. Figure 5A / B shows the monocyte distribution under the influence of a 2-week treatment with 1,8-cineole, or before and after 2 weeks of treatment with 1,8-cineole. The studies show a strong response to the intake of 1,8-cineole, with a significant increase in CD16 "classical" monocytes ("CD16 neg.") in the patients studied. Fig. 5A") and at the same time a significant decrease in "intermediate" monocytes ("CD16 pos."; Fig. 5B") after treatment with 1,8-cineole (in Fig. 5A / B, the respective left circle representation shows the situation before cineole treatment and the respective right box representation shows the situation after cineole treatment).

[0202] Fig. Figure 5 A / B shows the monocyte distribution under the influence of a 2-week treatment with 1,8-cineole, demonstrating a strong response to the intake of 1,8-cineole. In the patients studied, a significant increase in CD16-classical monocytes ( Fig. 5A) and at the same time a significant decrease in the number of intermediate monocytes ( Fig. 5B). Example 3: Patient perceptions and clinical applications

[0203] As explained above, 1,8-cineole not only exerts a positive effect on the intestinal epithelium and its immune cells at its primary site of action, namely the human intestine, but also improves the corresponding immune status (i.e., induces active or primary anti-inflammatory mediation). This, in turn, leads to a systemically relevant improvement in inflammatory processes or parameters in the human body during clinical application. This can be demonstrated by the treatment of various inflammatory diseases of the human body (which is an indication of organ-nonspecific or region-nonspecific and thus systemically universal anti-inflammatory effects).

[0204] In addition to the molecular biological studies, the patients' individual perceptions and quality of life regarding the 2-week intake of 1,8-cineole are also being assessed. The response from the polyposis patients included in the study was predominantly positive regarding the 2-week intake of 1,8-cineole.

[0205] In 38 patients (23 men / 15 women between 28 and 72 years, average age 54 years) each with nasal polyposis, therapy with 1,8-cineole was carried out (3 x 200 mg 1,8-cineole in the form of capsules “Soledum ® forte”).

[0206] Treated patients report significantly improved secretion drainage and correspondingly improved nasal breathing. In one case, the patient was diagnosed with relatively small nasal polyps located directly on the olfactory groove. After two weeks of taking 1,8-cineole, this patient experienced a significant reduction in the polyps, along with a significant improvement in olfactory perception. Example 4: 1,8-Cineole in clinical use

[0207] In addition, the effect of 1,8-cineole is being further investigated based on the following areas of application, whereby 200 mg of 1,8-cineole is administered 3 times daily over the specified period (Soledum ® forte): 1. Chronic polypous sinusitis 2. Chronic recurrent catarrhal sinusitis 3. Chronic polypous otitis media without cholesteatoma 4. Chronic polypous otitis media with cholesteatoma

[0208] Ad 1. After 2 weeks of administration (preoperatively), there was a reduction in the accompanying symptoms of the polyps, such as anterior and posterior watery rhinorrhea. In individual cases, there was also an improvement in olfactory function. Postoperatively, there was a positive effect on wound healing and, in combination with a nasal steroid, a reduction in recurrences and the need for systemic cortisone administration.

[0209] Ad 2. After 2 weeks of administration (preoperatively), there was a reduction in the accompanying symptoms of the polyps, such as anterior and posterior watery rhinorrhea; a significant improvement in olfactory function; postoperatively, a positive effect on wound healing, and a reduction in nasal steroids.

[0210] Ad 3. After 2 weeks of administration (preoperatively) in cases of previously refractory otorrhea (local and systemic antibiotics), remission of otorrhea, allowing surgery; in cases of post-tympanoplasty, recurrent otorrhea with recurrent perforation; after 4 weeks of administration, remission of otorrhea and spontaneous closure of the tympanic membrane.

[0211] Ad 4. ​​After 2 weeks of administration (preoperatively) in previously refractory otorrhea (local and systemic antibiotics), the accompanying otorrhea subsided, allowing surgery; no reduction in cholesteatoma masses, but a positive effect on the inflamed mucosa of the middle ear and mastoid; in patients after tympanoplasty, otorrhea recurred, resulting in recurrent perforation. After 4 weeks of administration, otorrhea subsided, and the eardrum closed spontaneously. Example 5: 1,8-Cineole in further clinical use

[0212] Patients with persistent bronchial asthma who are treated with a combination therapy of inhaled glucocorticoid and inhaled long-acting beta-2 sympathomimetic as well as theophylline orally receive 1,8-cineole (Soledum ®forte capsules) 4 x 200 mg / day orally. A slight to moderate improvement in lung function can be achieved after just one week of treatment with the above-mentioned dose. After twelve weeks of continuous therapy, the persistent bronchial asthma has stabilized to such an extent that the inhaled glucocorticoid requirement can be reduced by more than 50%, and in some treated patients, glucocorticoids can even be discontinued completely for a time. In some patients, the need for beta-mimetics can also be significantly reduced. Treatment with 1,8-cineole is well tolerated without side effects. The trial results demonstrate that, due to its anti-inflammatory effect, 1,8-cineole can significantly increase the efficacy of inhaled respiratory medications and thus significantly reduce their dosage requirements.

[0213] Overall, therefore, based on the surprisingly discovered findings of the applicant, cineole, preferably 1,8-cineole, is efficiently suitable for use in reducing pathogenic germs in the human intestine or for use in reducing the colonisation of the human intestine with pathogenic germs, preferably for the purposes of preventing, reducing or curing inflammatory diseases of the human body or preferably for the purposes of the prophylactic and / or therapeutic treatment of inflammatory diseases of the human body.

Claims

[1] Cineole for use in reducing pathogenic germs in the human intestine and in reducing the colonization of the human intestine with pathogenic germs and equally for use in increasing the colonization of the human intestine with health-promoting or non-pathogenic germs. [2] Cineole for use according to claim 1, wherein the cineole is 1,8-cineole. [3] Cineole for use according to claim 1 or 2, for the purposes of preventing, reducing or curing inflammatory diseases of the human body and / or for the purposes of prophylactic and / or therapeutic treatment of inflammatory diseases of the human body. [4] Cineole for use according to one of the preceding claims, wherein the cineole is used or employed to reduce the germ load and / or the number of pathogenic germs in the human intestine and / or to reduce the proportion of pathogenic germs, based on the total number of germs in the human intestine, in particular in the human intestinal flora. [5] Cineole for use according to any one of the preceding claims, wherein the pathogenic germs are selected from the group of germs that cause inflammation, that promote inflammation and that are associated with or induce inflammation in the human body, in particular from the group of germs that produce and / or release inflammation-causing and inflammation-promoting substances, and combinations thereof. [6] Cineole for use according to any one of the preceding claims, wherein the pathogenic germs are selected from the group of bacteria, in particular bacteria which adversely affect health and / or are harmful to health, preferably from the group of bacteria which cause inflammation, which induce inflammation and which are associated with or which cause inflammation in the human body, and combinations thereof. [7] Cineole for use according to any one of the preceding claims, wherein the pathogenic germs are selected from the group of bacteria from the family Prevotellaceae, preferably from the group of bacteria of the genus Prevotella. [8] Cineole for use according to any one of the preceding claims, wherein the cineole is equally used or employed to increase, multiply or support the health-promoting or non-pathogenic, preferably health-promoting, germs in the human intestine. [9] Cineole for use according to any one of the preceding claims, wherein the health-promoting or non-pathogenic, preferably health-promoting, germs are selected from the group of inflammation-reducing, anti-inflammatory and inflammation-inhibiting germs, in particular from the group of germs producing and / or releasing anti-inflammatory and inflammation-inhibiting substances, and combinations thereof. [10] Cineole for use according to any one of the preceding claims, wherein the health-promoting or non-pathogenic, preferably health-promoting, germs are selected from the group of bacteria, in particular bacteria which have a positive influence on health and / or are health-promoting, preferably from the group of inflammation-reducing, anti-inflammatory and inflammation-inhibiting bacteria, and combinations thereof. [11] Cineole for use according to any one of the preceding claims, wherein the health-promoting or non-pathogenic, preferably health-promoting, germs are selected from the group of bacteria of the Ruminococcacea family, preferably from the group of bacteria of the genus Ruminococcus. [12] Cineole for use according to any one of the preceding claims, wherein the health-promoting or non-pathogenic, preferably health-promoting, germs are selected from the group of bacteria of the families Bacteroidaceae, Lachnospiraceae and Bifidobacteriaceae, in particular Bacteroidaceae and Lachnospiraceae, preferably Bacteroidaceae, and combinations thereof; and / or wherein the health-promoting or non-pathogenic, preferably health-promoting, germs are selected from the group of bacteria of the genus Bacteroides, Lachnospira and Bifidobacterium, in particular Bacteroides and Lachnospira, preferably Bacteroides, and combinations thereof. [13] Cineole for use according to any one of the preceding claims, wherein the cineole is equally used or employed for the regeneration and / or rehabilitation of the bacterial colonization of the human intestine. [14] Cineole for use according to any one of the preceding claims, wherein the cineole is used or employed equally to increase the bacterial diversity and / or to diversify the bacterial colonization of the human intestine. [15] Cineole for use according to any one of the preceding claims, wherein the cineole is equally used or employed as an anti-inflammatory agent, in particular as a systemically acting anti-inflammatory agent. [16] Cineole for use according to any one of the preceding claims, wherein the cineole is equally used or employed for suppressing or attenuating an inflammatory mediation occurring in the context of inflammatory diseases of the human body. [17] Cineole for use according to any one of the preceding claims, where the inflammatory diseases of the human body are related to the pathogenic germs in the human intestine or are caused and / or induced and / or aggravated thereby; and / or wherein the inflammatory diseases of the human body are associated with an excessive and / or abnormal and / or pathological colonization, in particular overgrowth, of the human intestine with the pathogenic germs or are caused and / or induced and / or aggravated thereby. [18] Cineole for use according to any one of the preceding claims, wherein the inflammatory diseases of the human body are acute inflammatory diseases or chronic inflammatory diseases. [19] Cineole for use according to any one of the preceding claims, wherein the cineole is prepared for systemic, in particular peroral or parenteral, preferably peroral, administration. [20] Cineole for use according to any one of the preceding claims, wherein the cineole is prepared in a dosage form for oral administration. [21] Cineole for use according to any one of the preceding claims, wherein the cineole is prepared for administration as a gastro-resistant but small intestine-soluble systemic dosage form, preferably as a capsule, dragee, pill, tablet or the like. [22] Cineole for use according to any one of the preceding claims, wherein the cineole is prepared for administration in pharmaceutically effective and / or therapeutically effective amounts; and / or wherein the cineole is prepared for administration at a daily dose in the range of 1 to 5,000 mg / diem, in particular in the range of 2 to 3,000 mg / diem, preferably in the range of 5 to 2,500 mg / diem, more preferably in the range of 10 to 2,000 mg / diem, particularly preferably in the range of 50 to 1,500 mg / diem. [23] Cineole for use according to any one of the preceding claims, wherein the cineole is present and / or administered as a pure substance; in particular wherein the cineole is present and / or administered with a purity of at least 95% by weight, in particular at least 96% by weight, preferably at least 97% by weight, particularly preferably at least 98% by weight, very particularly preferably at least 99% by weight, even more preferably at least 99.5% by weight, based on the cineole; and / or in particular wherein the cineole is free from other terpenes and / or in particular wherein the cineole does not contain other terpenes. [24] Cineole for use according to any one of the preceding claims, wherein the cineole is present and / or administered together with at least one physiologically acceptable carrier; in particular wherein the physiologically acceptable carrier is miscible with cineole and / or soluble therein; and / or in particular wherein the physiologically acceptable carrier is in the liquid or solid, preferably liquid, state at 20 °C and at atmospheric pressure; and / or in particular wherein the physiologically acceptable carrier is selected from the group of fatty acid esters, preferably triglycerides of fatty acids, particularly preferably medium-chain triglycerides, very particularly preferably triglycerides of C6-C 12 -fatty acids. [25] Cineole for use according to any one of the preceding claims, wherein the cineole is present and / or administered in and / or in the form of a composition, in particular a pharmaceutical composition, in particular together with at least one pharmaceutically acceptable and / or physiologically acceptable carrier; in particular wherein the composition contains cineole as the sole active ingredient, in particular as the sole pharmaceutical active ingredient; and / or in particular wherein the composition contains cineole as a pure substance, preferably with a purity of at least 95% by weight, in particular at least 96% by weight, preferably at least 97% by weight, particularly preferably at least 98% by weight, very particularly preferably at least 99% by weight, even more preferably at least 99.5% by weight, based on the cineole, and / or preferably free from other terpenes; and / or in particular wherein the composition contains the cineole at least substantially free from other terpenes and / or in particular wherein the composition contains at least substantially no further terpene and / or in particular wherein the composition is at least substantially free from terpenes other than cineole; and / or in particular wherein the composition contains the cineole in effective, in particular pharmaceutically and / or therapeutically effective, amounts; and / or in particular wherein the composition contains the cineole, based on the composition, in relative amounts in the range of 0.0001 to 80 wt.%, in particular in the range of 0.001 to 75 wt.%, preferably in the range of 0.005 to 70 wt.%, preferably in the range of 0.01 to 60 wt.%, particularly preferably in the range of 0.05 to 55 wt.%, very particularly preferably in the range of 0.1 to 50 wt.%; and / or in particular wherein the at least one pharmaceutically acceptable and / or physiologically acceptable carrier is miscible with cineole and / or soluble therein, preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable carrier is in the liquid or solid, preferably liquid, state of aggregation at 20 °C and at atmospheric pressure and / or preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable carrier is selected from the group of fatty acid esters, preferably triglycerides of fatty acids, particularly preferably medium-chain triglycerides, very particularly preferably triglycerides of C6-C 12 -fatty acids. [26] Cineole for use according to any one of the preceding claims, wherein the cineole is present and / or administered in micellized form and / or in a micellar dosage form. [27] Cineole for use according to any one of claims 1 to 26, wherein the cineole is present and / or administered as a single active ingredient and / or as a monopreparation; and / or wherein the cineole is present and / or administered without and / or in the absence of other active substances other than cineole. [28] Cineole for use according to any one of claims 1 to 26, wherein the cineole is present and / or administered together with at least one other active ingredient and / or as a co-therapeutic agent; in particular wherein the further active ingredient is selected from (i) anti-inflammatory agents, in particular non-steroidal anti-inflammatory agents or steroidal anti-inflammatory agents, preferably steroidal anti-inflammatory agents, preferably corticosteroids; (ii) antibiotics; (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; and combinations thereof; and / or in particular wherein the further active ingredient is used and / or administered separately, in particular spatially separated, from the cineole but functionally connected therewith, in particular in the form of a kit. [29] Cineole for use according to any one of claims 1 to 26 or according to claim 28, wherein the cineole is present and / or administered together with at least one prebiotic; in particular wherein the prebiotic is a substance which specifically promotes the growth of microorganisms that have a positive effect on the intestinal flora; and / or in particular wherein the prebiotic is selected from the group of in particular natural polysaccharides, in particular natural oligosaccharides, and sugar alcohols; and / or in particular wherein the prebiotic is gum arabic; and / or in particular wherein the prebiotic is selected from the group of fructooligosaccharides and galactooligosaccharides, in particular each in the form of tri- to pentasaccharides, and combinations thereof; and / or in particular wherein the prebiotic is selected from the group of inulin, sucrose, stachyose, raffinose, lactulose and combinations thereof. [30] Cineole for use according to any one of claims 1 to 26 and 28 or 29, wherein the cineole is present and / or administered together with microorganisms that positively influence the intestinal flora; in particular wherein the microorganisms are selected from the group of yeasts and bacteria; and / or in particular wherein the microorganisms are selected from the group of species of the genus Saccharomyces, in particular Saccharomyces boulardii and Saccharomyces cervesiae, preferably Saccharomyces boulardii, and combinations thereof; and / or in particular wherein the microorganisms are selected from the group of species of the genus Bifidobacterium, Lactobacillus, Enterococcus, Escherichia, Streptococcus, in particular in the form of species which positively influence the intestinal flora, and combinations thereof; and / or in particular wherein the microorganisms are present and / or administered as a dry substance, in particular biologically active dry substance, in particular in lyophilized form and / or as a lyophilisate. [31] Cineole for use according to any one of the preceding claims, for use in the prophylactic and / or therapeutic treatment of dysbiosis and / or of colonisation of the human intestine with pathogenic germs. [32] Use of cineole to reduce pathogenic germs in the human intestine and to reduce the colonization of the human intestine with pathogenic germs and equally to increase the colonization of the human intestine with health-promoting or non-pathogenic germs. [33] Use of cineole, in particular use according to claim 32, for the prophylactic and / or therapeutic treatment of dysbiosis and / or of colonisation of the human intestine with pathogenic germs. [34] Medicine or drug for use in reducing pathogenic germs in the human intestine and in reducing the colonisation of the human intestine with pathogenic germs and equally for use in increasing the colonisation of the human intestine with health-promoting or non-pathogenic germs, wherein the medicinal product or medicament contains cineole together with at least one pharmaceutically acceptable and / or physiologically acceptable carrier. [35] Medicinal product or medicament, in particular medicinal product or medicament according to claim 34, for the prophylactic and / or therapeutic treatment of dysbiosis and / or colonization of the human intestine with pathogenic germs, wherein the drug or medicament contains the cineole together with at least one pharmaceutically acceptable and / or physiologically acceptable carrier. [36] A medicinal product or medicament according to claim 34 or 35, wherein the medicinal product or medicament contains cineole as the sole active ingredient, in particular as the sole pharmaceutical active ingredient; and / or wherein the medicinal product or medicament contains cineole as a pure substance, preferably with a purity of at least 95% by weight, in particular at least 96% by weight, preferably at least 97% by weight, particularly preferably at least 98% by weight, very particularly preferably at least 99% by weight, even more preferably at least 99.5% by weight, based on the cineole, and / or preferably free from other terpenes; and / or wherein the medicinal product or medicament contains the cineole free from other terpenes and / or wherein the medicinal product or medicament contains no further terpene and / or wherein the medicinal product or medicament is free from terpenes other than cineole; and / or wherein the medicinal product or medicament contains the cineole in effective, in particular pharmaceutically and / or therapeutically effective, amounts; and / or wherein the medicinal product or medicament contains the cineole, based on the medicinal product or Medicament, in relative amounts in the range of 0.0001 to 80 wt.%, in particular in the range of 0.001 to 75 wt.%, preferably in the range of 0.005 to 70 wt.%, preferably in the range of 0.01 to 60 wt.%, particularly preferably in the range of 0.05 to 55 wt.%, most preferably in the range of 0.1 to 50 wt.%; and / or wherein the at least one pharmaceutically acceptable and / or physiologically acceptable carrier is miscible with cineole and / or soluble therein, preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable carrier is in the liquid or solid, preferably liquid, state of aggregation at 20°C and at atmospheric pressure and / or preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable carrier is selected from the group of fatty acid esters, preferably triglycerides of fatty acids, particularly preferably medium-chain triglycerides, very particularly preferably triglycerides of C6-C 12 -fatty acids. [37] Pharmaceutical composition for use in reducing pathogenic germs in the human intestine and for use in reducing the colonisation of the human intestine with pathogenic germs and equally for use in increasing the colonisation of the human intestine with health-promoting or non-pathogenic germs, wherein the composition contains cineole, in particular together with at least one pharmaceutically acceptable and / or physiologically acceptable carrier. [38] Pharmaceutical composition, in particular composition according to 37, for use in the prophylactic and / or therapeutic treatment of dysbiosis and / or of colonisation of the human intestine with pathogenic germs, wherein the composition contains cineole, in particular together with at least one pharmaceutically acceptable and / or physiologically acceptable carrier. [39] Composition for use according to claim 37 or 38, wherein the composition contains cineole as the sole active ingredient, in particular as the sole pharmaceutical active ingredient; and / or wherein the composition contains cineole as a pure substance, preferably with a purity of at least 95% by weight, in particular at least 96% by weight, preferably at least 97% by weight, particularly preferably at least 98% by weight, very particularly preferably at least 99% by weight, even more preferably at least 99.5% by weight, based on the cineole, and / or preferably free from other terpenes; and / or wherein the composition contains the cineole free from other terpenes and / or wherein the composition contains no further terpene and / or wherein the composition is free from terpenes other than cineole; and / or wherein the composition contains the cineole in effective, in particular pharmaceutically and / or therapeutically effective, amounts; and / or wherein the composition contains the cineole, based on the composition, in relative amounts in the range of 0.0001 to 80 wt.%, in particular in the range of 0.001 to 75 wt.%, preferably in the range of 0.005 to 70 wt.%, preferably in the range of 0.01 to 60 wt.%, particularly preferably in the range of 0.05 to 55 wt.%, very particularly preferably in the range of 0.1 to 50 wt.%; and / or wherein the at least one pharmaceutically acceptable and / or physiologically acceptable carrier is miscible with cineole and / or soluble therein, preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable carrier is in the liquid or solid, preferably liquid, state of aggregation at 20°C and at atmospheric pressure and / or preferably wherein the at least one pharmaceutically acceptable and / or physiologically acceptable carrier is selected from the group of fatty acid esters, preferably triglycerides of fatty acids, particularly preferably medium-chain triglycerides, very particularly preferably triglycerides of C6-C 12 -fatty acids. [40] Cineole for use according to any one of claims 1 to 31, use according to claim 32 or 33, medicament or drug according to any one of claims 34 to 36 and composition according to any one of claims 37 to 39, wherein the cineole, preferably 1,8-cineole, in particular the drug or medicament or composition, is prepared for administration in pharmaceutically effective and / or therapeutically effective amounts; and / or wherein the cineole, in particular the drug or medicament or the composition, is administered systemically; and / or wherein the cineole, in particular the pharmaceutical or medicament or the composition, is used or administered together with at least one further active ingredient, in particular wherein the further active ingredient is selected from the group of (i) anti-inflammatory active ingredients, in particular non-steroidal anti-inflammatories or steroidal anti-inflammatories, preferably steroidal anti-inflammatories, preferably corticosteroids; (ii) antibiotics; (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; and combinations thereof. [41] Pharmaceutical combination for use in reducing pathogenic germs in the human intestine and in reducing the colonisation of the human intestine with pathogenic germs and equally for use in increasing the colonisation of the human intestine with health-promoting or non-pathogenic germs, wherein the pharmaceutical combination comprises at least the following components (A) and (B): (A) Cineole; and (B) at least one further active ingredient selected from the group of (i) anti-inflammatory agents, in particular non-steroidal anti-inflammatories or steroidal anti-inflammatories, preferably steroidal anti-inflammatories, preferably corticosteroids; (ii) antibiotics; (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; and combinations thereof. [42] Pharmaceutical combination, in particular pharmaceutical combination according to claim 41, for use in the prophylactic and / or therapeutic treatment of dysbiosis and / or of human colonisation with pathogenic germs, wherein the pharmaceutical combination comprises at least the following components (A) and (B): (A) Cineole; and (B) at least one further active ingredient selected from the group of (i) anti-inflammatory agents, in particular non-steroidal anti-inflammatories or steroidal anti-inflammatories, preferably steroidal anti-inflammatories, preferably corticosteroids; (ii) antibiotics; (iii) prebiotics; and (iv) microorganisms that positively influence the intestinal flora; and combinations thereof. [43] Pharmaceutical combination according to claim 41 or 42, wherein the components (A) and (B) are present and / or administered separately from one another, in particular spatially separated from one another, but functionally connected and / or functionally associated with one another; and / or wherein the pharmaceutical combination is in the form of a kit, in particular as a kit of components (A) and (B), and / or wherein components (A) and (B) are present and / or prepared and / or administered as a kit. [44] Use according to claim 32 or 33, medicament or drug according to any one of claims 34 to 36, composition according to any one of claims 37 to 39 and pharmaceutical combination according to any one of claims 41 to 43, each characterized by one or more of the features of claims 1 to 31.

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