USE OF A LIMOSILACTOBACILLUS FERMENTUM BACTERIAL STRAIN ALONE OR IN COMBINATION WITH SACCHAROMYCES CEREVISIAE FOR THE PREVENTION AND / OR TREATMENT OF VAGINAL CANDIDOSIS

Description

Technical field

[0001] The present invention falls within the field of vaginal health. It relates in particular to the use of new bacterial strains. Limosilactobacillus fermentum, in the prevention and / or treatment of vaginal candidiasis. The invention also relates to the use of these new bacterial strains. Limosilactobacillus fermentum in association with Saccharomyces cerevisiae in the prevention and / or treatment of vaginal candidiasis. Previous technique

[0002] Vaginal or vulvovaginal candidiasis (also called vaginal or vulvovaginal mycoses) is caused primarily by infection with pathogenic fungi, namely yeasts of the type Candida albicans (hence the name candidiasis) in the intimate area of ​​women. Candida albicans,Naturally present in the vaginal microbiota, it can proliferate abnormally and lead to the development of vaginal candidiasis. Vaginal candidiasis, or yeast infections, causes itching as well as inflammation of the vulva and vagina.

[0003] Vaginal yeast infections are currently considered a significant public health problem and are the second leading cause of vaginal infection after bacterial vaginosis. It is estimated that 75% of women will develop a vaginal yeast infection at some point in their lives. Approximately 50% of women experience at least two to three episodes of vaginal yeast infections during their lifetime. Between 10% and 20% of women suffer from recurrent vaginal yeast infections, with an average of four episodes per year.

[0004] The antifungal treatments commonly used today are based on chemical molecules, primarily azole derivatives such as fluconazole, ketoconazole, econazole, miconazole, or clotrimazole, generally administered as a cream or vaginal suppository. In some cases, oral treatment is used in addition to topical treatment.

[0005] However, one of the major problems with this type of treatment is that, in cases of recurrent vaginal yeast infections, the pathogenic fungus, in particular Candida albicans, may develop resistance to existing antifungal treatments.

[0006] Another problem with using azole derivatives to treat fungal infections is the sensation of irritation and burning in the vulva.

[0007] In order to offer alternatives to treatments based on azole derivatives, probiotics have been described in the literature.

[0008] In 2001, probiotics were defined by the World Health Organization (WHO) as "live microorganisms which, when administered in adequate amounts, confer a health benefit beyond traditional nutritional effects."

[0009] The PCT / SE2006 / 001311 document describes the use of a strain of Lactobacillus fermentum “Ess-1”, registered with the “Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH” under number “DSM17851”, in the prevention and / or treatment of vaginal candidiasis.

[0010] The document PCT / FR2013 / 051643 describes the use of a strain Saccharomyces cerevisiae filed with the CNCM under number I-3856 in the prevention and / or treatment of vaginal mycoses, and in particular vaginal candidiasis.

[0011] Probiotics do not present the aforementioned drawbacks of chemical treatments (resistance, side effects such as irritation and burning) while offering at least comparable efficacy. Probiotics thus represent natural alternatives to chemical molecules, without adverse effects. Summary

[0012] One of the objectives of the present invention is therefore to propose new probiotics to prevent and / or treat vaginal candidiasis.

[0013] The present inventors have found, surprisingly, that the use of at least one bacterial strain Limosilactobacillus fermentum filed on November 17, 2021 with the CNCM (National Collection of Microorganism Cultures, 25, rue du Docteur Roux, 75724 Paris cedex 15, France) under number I-5777 or under number I-5778 made it possible to achieve this objective.

[0014] An object of the invention thus resides in a stump Limosilactobacillus fermentum chosen from the strain filed with the CNCM on November 17, 2021 under number I-5777 or under number I-5778.

[0015] It is recalled that the probiotic effect of a given strain, whether it is a strain of bacteria or a strain of yeast, is specific to that strain, and not to the genus and species considered.

[0016] Another object of the invention lies in a stump Limosilactobacillus fermentum chosen from the strain filed with the CNCM on November 17, 2021 under number I-5777 or under number I-5778, for its use in the prevention and / or treatment of vaginal candidiasis.

[0017] The strain Limosilactobacillus fermentum is a bacterial strain or bacterial strain. The term "bacterial strain" refers to a relatively homogeneous population of bacterial cells.

[0018] A bacterial strain is obtained from the isolation of a clone, a clone being a population of cells obtained from a single bacterial cell.

[0019] The present invention also relates to the bacterium obtained by culturing the strain Limosilactobacillus fermentum chosen from the strain filed with the CNCM on November 17, 2021 under number I-5777 or under number I-5778, for its use in the prevention and / or treatment of vaginal candidiasis, for its use in the prevention and / or treatment of vaginal candidiasis.

[0020] In this application, the term "bacteria" is used in the singular, but it could also be used in the plural. "Bacterium" thus refers to the bacterium or bacteria obtained by culturing the strain Limosilactobacillus fermentum as defined above. In this application, the terms "bacteria obtained by culture of the strain" shall be used interchangeably. Limosilactobacillus fermentumfiled with the CNCM on November 17, 2021 under number I-5777”, “bacteria obtained by culture of strain I-5777” and “bacteria I-5777”, these three terms having the same meaning as that given above for the term “bacteria”.

[0021] Similarly, in this application, the terms "bacteria obtained by culture of the strain" will be used interchangeably. Limosilactobacillus fermentum filed with the CNCM on November 17, 2021 under number I-5778", "bacteria obtained by culture of strain I-5778" and "bacteria I-5778", these three terms having the same meaning as given above.

[0022] The terms "bacterial strain", "bacterial strain", "strain" Limosilactobacillus fermentum " mean, for the purposes of this application, strain I-5777 and / or strain I-5778.

[0023] The bacteria Limosilactobacillus fermentum of the invention means, for the purposes of this application, the bacterium I-5777 and / or the bacterium I-5778.

[0024] As an example, the bacteria Limosilactobacillus fermentum of the invention can be obtained by culturing strain I-5777 or strain I-5778, at 37°C, without agitation, in a culture medium "MRS broth" ("Man Rogosa Sharpe") (Biomerieux - AEB140652) at a pH of 6.5 overnight.

[0025] The bacteria Limosilactobacillus fermentum However, it can also be obtained by an industrial-scale process which includes the following steps: culture of the bacterial strain in an optimal medium for biomass production, separation by centrifugation of the bacteria thus produced from its culture medium, to obtain a concentrated cream biomass containing 10 to 20% dry matter, said concentrated biomass being called "centrifuge", freezing of the centrifuge, preferably with liquid nitrogen, possibly storage at -80°C of the frozen centrifuge for a period of up to one year, drying by freeze-drying of the frozen centrifuge to obtain a powder containing 90 to 98% dry matter.

[0026] The powder obtained by freeze-drying corresponds to what is meant in this application by "dry form, preferably freeze-dried".

[0027] According to one embodiment of the invention, the bacterium as defined above, for its use in the prevention and / or treatment of vaginal candidiasis, is presented in frozen form or in dry form, preferably in dry form, and even more preferably in freeze-dried dry form.

[0028] According to an advantageous embodiment of the invention, the bacterial strain or bacterium I-5777 is used, for its use in the prevention and / or treatment of vaginal candidiasis, in dry form, preferably lyophilized, at a daily dose of 1x10⁷ to 1x10¹⁰ CFU, preferably 2x10⁸ to 2x10⁹ CFU.

[0029] According to yet another advantageous embodiment of the invention, the bacterial strain or bacterium I-5778 is used, in dry form, preferably lyophilized, for its use in the prevention and / or treatment of vaginal candidiasis, at a daily dose of 1x10⁷ to 1x10¹⁰ CFU, preferably 2x10⁸ to 2x10⁹ CFU.

[0030] The acronym "UFC" stands for "Colony Forming Unit".

[0031] The term "vaginal" is used broadly in this application and the terms "vaginal" and "vulvo-vaginal" are synonymous here.

[0032] The term "vaginal candidiasis" refers to a specific type of vaginal yeast infection caused by fungi of the genus White, such as those chosen from the group including Candida albicans, Candida tropicalis, Candida pseudotropicalis, Candida krusei, Candida glabrata and their mixtures.

[0033] Vaginal candidiasis is also called candidal vaginitis.

[0034] According to another embodiment, the invention relates to a strain of Limosilactobacillus fermentum such as defined above or a bacterium Limosilactobacillus fermentum as defined above, for its use in the prevention and / or treatment of vaginal candidiasis due to fungi selected from the group comprising Candida albicans, Candida tropicalis, Candida pseudotropicalis, Candida krusei, Candida glabrata and their mixtures.

[0035] The strain Limosilactobacillus fermentum or the bacteria Limosilactobacillus fermentum can be used preventively in women with predispositions and / or sensitivity to vaginal candidiasis, or curatively, for example during infectious episodes.

[0036] The present inventors also discovered that when one or both of these two strains of bacteria were associated with the strain Saccharomyces cerevisiaefiled on October 17, 2007 with the CNCM (National Collection of Microorganism Cultures, 25, rue du Docteur Roux, 75724 Paris cedex 15, France) under number I-3856, then a particularly surprising synergistic effect was obtained leading to particularly effective means of treating vaginal candidiasis.

[0037] In this regard, another object of the invention lies in a strain of bacteria or bacterium Limosilactobacillus fermentum as defined above, for use in the prevention and / or treatment of vaginal candidiasis, characterized in that it is used in combination with the strain Saccharomyces cerevisiae filed with the CNCM on October 17, 2017 under number I-3856 and / or with the yeast obtained by culturing said strain Saccharomyces cerevisiae.

[0038] The strain of Saccharomyces cerevisiaeis a yeast strain. The term "yeast strain" refers to a relatively homogeneous population of yeast cells. A yeast strain is obtained from the isolation of a clone, a clone being a population of cells obtained from a single yeast cell.

[0039] Yeast Saccharomyces cerevisiae refers, for the purposes of this application, to yeast I-3856.

[0040] Thus, according to one embodiment of the invention, the bacterial strain or bacterium Limosilactobacillus fermentum may be associated with the strain Saccharomyces cerevisiae and / or yeast Saccharomyces cerevisiae.

[0041] In other words, according to an advantageous embodiment of the invention, the bacterium(s) Limosilactobacillus fermentum I-5777 and / or I-5778 is / are associated with yeast Saccharomyces cerevisiae I-3856.

[0042] For example, yeast Saccharomyces cerevisiaecan be obtained by culturing strain number I-3856 in a culture medium, for example as described in the reference book "Yeast Technology", 2nd edition, 1991, G. Reed and TW Nagodawithana, published by Van Nostrand Reinhold, ISBN 0-442-31892-8.

[0043] However, Sc I-3856 yeast can also be obtained by an industrial-scale process which includes the following steps: culture of a yeast strain in a multi-stage culture medium, first in semi-anaerobic conditions, then in aerobic conditions, separation by centrifugation of the yeast thus produced from its culture medium, to obtain a liquid yeast cream containing 12 to 25% dry matter, or even a higher amount of dry matter, especially if the yeast cream is mixed with osmolyte products.

[0044] In this application, the terms "yeast obtained by culture of the strain" shall be used interchangeably. Saccharomyces cerevisiaefiled with the CNCM under number I-3856", "yeast obtained by culture of strain I-3856" and "yeast Sc I-3856", these three terms having the same meaning as given above.

[0045] The strain Saccharomyces cerevisiae filed with the CNCM under number I-3856 can still be referred to as "strain Sc I-3856".

[0046] According to yet another advantageous embodiment of the invention, the yeast Sc I-3856, used in association with the bacterial strain or bacteria Limosilactobacillus fermentum, is alive. Live yeast is then presented in the form of dry yeast or fresh yeast, preferably in the form of dry yeast.

[0047] For example, in the case of the association of the yeast Sc I-3856 with the bacterial strain or bacterium Limosilactobacillus fermentum, to prevent and / or treat vaginal candidiasis: the bacterial strain or bacteria Limosilactobacillus fermentum,in dry form, preferably freeze-dried, is used at a daily dose of 1x10⁷ to 1x10¹⁰ CFU, preferably 2x10⁸ to 2x10⁹ CFU and, yeast Sc I-3856, in dry form, is used at a daily dose of 1x10⁷ to 1x10¹¹ CFU, preferably 1x10⁹ to 1x10¹² CFU, and even more preferably 2.5x10⁹ to 5x10⁹ CFU.

[0048] Fresh yeast is characterized by a high water content. Fresh yeast is chosen, for example, from liquid yeast or compressed yeast.

[0049] Liquid yeast, also called "liquid yeast cream", is an aqueous suspension comprising 12% to 50% dry yeast matter, more generally 12% to 25% dry yeast matter.

[0050] Pressed yeast is obtained by a / filtering a liquid yeast cream, generally on a rotary vacuum filter, to obtain a dehydrated fresh yeast containing 26% to 37% dry matter, and by b / kneading said dehydrated fresh yeast and c / extrusion.

[0051] Pressed yeast contains 26% to 37% yeast dry matter. Pressed yeast may or may not be crumbled.

[0052] Examples of dry yeasts include active dry yeast, instant dry yeast, and frozen intermediate moisture yeast.

[0053] One advantage of dry yeast is its long shelf life.

[0054] An active dry yeast or an instant dry yeast comprises a yeast dry matter content greater than 90%, preferably a dry matter content between 92% and 96%.

[0055] Active dry yeast is obtained by dehydrating pressed or liquid yeast through the combined action of heat (at low temperature) and mechanical activity, which transforms a paste-like product (pressed or liquid yeast) into a dry product in the form of spherules. For example, active dry yeast is obtained by extruding and fluidizing pressed or liquid yeast.

[0056] Active dry yeast is in the form of spherules whose diameter is generally between 0.1 µm and 2.5 mm.

[0057] Instant dry yeast is obtained by dehydrating compressed or liquid yeast using a hot air gradient, which transforms the paste-like product (compressed or liquid yeast) into fine, dry granules. To maintain its stability, instant dry yeast must then be stored in an oxygen-free environment.

[0058] For example, frozen dry yeast with intermediate moisture content comprises 70% to 85% yeast dry matter.

[0059] According to yet another advantageous embodiment of the invention, the yeast Sc I-3856, used in association with the bacterial strain or bacteria Limosilactobacillus fermentum, in the prevention and / or treatment of vaginal yeast infections, it is presented in the form of active dry yeast or in the form of instant dry yeast.

[0060] According to yet another advantageous embodiment of the invention, the yeast Sc I-3856, used in association with the bacterial strain or bacteria Limosilactobacillus fermentum, in the prevention and / or treatment of vaginal yeast infections, it is presented in the form of dead yeast, also called deactivated yeast.

[0061] A dead yeast is a yeast whose metabolism has irrevocably stopped.

[0062] Dead yeast can be obtained by techniques well known to those skilled in the art, such as heat treatment of the yeast, treatment consisting of subjecting the yeast to several successive freezing and thawing cycles, irradiation treatment, atomization treatment, or a combination of these treatments.

[0063] For example, in the case of the association of dead yeast with the bacterial strain or bacteria Limosilactobacillus fermentum, to prevent and / or treat vaginal candidiasis: the bacterial strain or bacteria Limosilactobacillus fermentum, in dry form, preferably freeze-dried, is used at a daily dose of 1x10⁷ to 1x10¹⁰ CFU, preferably 2x10⁸ to 2x10⁹ CFU and, yeast Sc I-3856, in the form of dead yeast, is used at a daily dose of 1 to 10,000 mg, and preferably 100 to 1,000 mg.

[0064] According to yet another advantageous embodiment of the invention, the yeast Sc I-3856, used in association with the bacterial strain or bacteria Limosilactobacillus fermentum, is used in the form of a yeast derivative, said derivative being selected from the cell wall of said yeast, the cell wall glucans of said yeast, the cell wall mannoproteins of said yeast or mixtures thereof.

[0065] The yeast cell wall broadly refers to both the cell wall and the plasma membrane of the yeast. Typically, the yeast cell wall is obtained through a process involving an autolysis step of the yeast followed by a separation step of the soluble fraction from the insoluble fraction; the isolated insoluble fraction corresponds to the yeast cell wall, which can then be dried.

[0066] For example, in the case of the association of a Sc I-3856 yeast cell wall with the bacterial strain or bacterium Limosilactobacillus fermentum, to prevent and / or treat vaginal candidiasis: the bacterial strain or bacteria Limosilactobacillus fermentum, in dry form, preferably freeze-dried, is used at a daily dose of 1x10⁷< to 1x10¹⁰< CFU, preferably 2x10⁸< to 2x10⁹< CFU and, yeast cell wall Sc I-3856 is used at a daily dose of 0.5 to 5,000 mg, preferably 50 to 500 mg.

[0067] For example, in the case of the association of cell wall glucans from yeast Sc I-3856 with the bacterial strain or bacterium Limosilactobacillus fermentum, to prevent and / or treat vaginal candidiasis: the bacterial strain or bacteria Limosilactobacillus fermentum, in dry form, preferably freeze-dried, is used at a daily dose of 1x10 7< to 1x10 10< CFU, preferably 2x10 8< to 2x10 9< CFU and, yeast cell wall glucans Sc I-3856 are used at a daily dose of 0.125 to 1250 mg, and preferably 12.5 to 125 mg.

[0068] As another example, in the case of the association of cell wall mannoproteins from yeast Sc I-3856 with the bacterial strain or bacterium Limosilactobacillus fermentum, to prevent and / or treat vaginal candidiasis: the bacterial strain or bacteria Limosilactobacillus fermentum, in dry form, preferably lyophilized, is used at a daily dose of 1x10 7< to 1x10 10< CFU, preferably 2x10 8< to 2x10 9< CFU and, yeast cell wall mannoproteins Sc I-3856 are used at a daily dose of 0.125 to 1250 mg, and preferably 12.5 to 125 mg.

[0069] According to an advantageous embodiment of the invention, the bacterial strain and / or bacteria Limosilactobacillus fermentum on the one hand and, the Sc I-3856 strain and / or Sc I-3856 yeast on the other hand, are administered simultaneously or sequentially, and preferably simultaneously.

[0070] When administration is sequential, yeast Sc I-3856 may, for example, be administered in the morning and bacterium(s) I-5777 and / or I-5778 in the evening.

[0071] Thus, the invention still relates to the bacterial strain and / or bacteria Limosilactobacillus fermentum, in association with Sc I-3856 strain and / or Sc I-3856 yeast, for simultaneous or sequential administration, for use in the prevention and / or treatment of vaginal candidiasis.

[0072] Depending on the desired administration method (simultaneous or sequential), the bacterial strain and / or bacteria Limosilactobacillus fermentum on the one hand, and the Sc I-3856 strain and / or Sc I-3856 yeast on the other hand, are found in the form of a single composition or in the form of a separate composition.

[0073] A unique composition means that the bacterial strain and / or bacteria Limosilactobacillus fermentumon the one hand and the Sc I-3856 strain and / or Sc I-3856 yeast on the other hand are found within a single composition.

[0074] A "separate" composition means that the bacterial strain and / or bacteria Limosilactobacillus fermentum is found in one composition and the Sc I-3856 strain and / or Sc I-3856 yeast is found in another composition, separate from the composition comprising the bacterial strain and / or bacteria.

[0075] According to a preferred embodiment, the invention relates to the bacterial strain and / or bacteria I-5777, in association with the Sc strain I-3856 and / or yeast Sc I-3856, for use in the prevention and / or treatment of vaginal candidiasis.

[0076] Preferably, the bacterial strain and / or bacteria I-5777 on the one hand, and the Sc strain I-3856 and / or yeast Sc I-3856 on the other hand, are present in a single composition and are therefore administered simultaneously.

[0077] According to another preferred embodiment, the invention relates to the bacterial strain and / or bacteria I-5778, in combination with the Sc strain I-3856 and / or yeast Sc I-3856, for use in the prevention and / or treatment of vaginal candidiasis. Preferably, the bacterial strain and / or bacteria I-5778, on the one hand, and the Sc strain I-3856 and / or yeast Sc I-3856, on the other hand, are present in a single composition and are therefore administered simultaneously.

[0078] Yet another object of the invention relates to a composition comprising: a strain Limosilactobacillus fermentum chosen from the strain filed with the CNCM on November 17, 2021 under number I-5777 or under number I-5778, and / or a bacterium obtained by culturing said strain Limosilactobacillus fermentum, possibly an excipient for its use in the prevention and / or treatment of vaginal candidiasis.

[0079] Another object of the invention lies in a composition comprising: a strain Limosilactobacillus fermentum chosen from the strain filed with the CNCM on November 17, 2021 under number I-5777 or under number I-5778, and / or a bacterium obtained by culturing said strain Limosilactobacillus fermentum, the strain Saccharomyces cerevisiae filed with the CNCM on October 17, 2007 under number I-3856 and / or the yeast obtained by culturing said strain Saccharomyces cerevisiae, possibly an excipient for its use in the prevention and / or treatment of vaginal candidiasis.

[0080] The composition according to the invention for use as defined above may be a pharmaceutical composition, a food supplement or a food composition.

[0081] Food composition refers to any food, beverage, or confectionery item. Examples of food composition include a cereal bar, chewing gum, and a dairy product.

[0082] When the composition is a food composition, then examples of excipients are lactose, corn starch, carboxymethylcellulose, mannitol, sucrose.

[0083] A "food supplement" is defined as a foodstuff whose purpose is to supplement the normal diet and which constitutes a concentrated source of nutrients or other substances having a nutritional or physiological effect, alone or in combination.

[0084] A food supplement is marketed in dose form, for example presentation forms such as capsule, lozenge, tablet, pill and other similar forms, sachet of powder, ampoule of liquid, bottle with dropper and other similar forms of liquid or powder preparations intended to be taken in small measured units.

[0085] The food composition and food supplement are intended for oral administration.

[0086] The pharmaceutical composition of the invention is intended for administration by the oral or vaginal route, preferably by the oral route. The excipients used in the pharmaceutical composition are commonly used excipients suitable for the preparation of oral or vaginal dosage forms.

[0087] Examples of pharmaceutical compositions presented in a form suitable for oral administration include tablets, capsules, softgels, sachets, powders, creams, syrups, and ampoules.

[0088] Examples of pharmaceutical compositions presented in a form suitable for vaginal administration include an ovule, a capsule, a softgel, a cream, or a tablet.

[0089] The daily dosage depends on both the method of administration (oral or vaginal) and the type of treatment (curative or preventive).

[0090] The composition for use as defined above is in a form suitable for administration by the oral or vaginal route, preferably by the oral route.

[0091] According to an advantageous embodiment of the invention, the composition for use as defined above does not comprise any active ingredients other than the strainLimosilactobacillus fermentum I-5777 and / or I-5778 and / or the bacteria Limosilactobacillus fermentum I-5777 and / or I-5778 on the one hand, and the Sc strain I-3856 and / or the Sc yeast I-3856 on the other hand.

[0092] Thus, the present invention also relates to a composition for use as defined above, characterized in that it comprises or is constituted: of the strain Limosilactobacillus fermentum I-5777 and / or I-5778 and / or the bacteria Limosilactobacillus fermentum I-5777 and / or I-5778 on the one hand, of the Sc strain I-3856 and / or of the Sc yeast I-3856 on the other hand, possibly of an excipient.

[0093] If the composition includes an excipient, then the excipient will be chosen according to the intended use of the composition (pharmaceutical, food, food supplement).

[0094] According to another advantageous embodiment of the invention, the composition for use as defined above is characterized in that it further comprises an active ingredient, in particular selected from the group including vitamin K, vitamin B9, glutathione, S-adenosyl-L-methionine (SAM-e), chondroitin sulfate, and mixtures thereof. Such a composition is preferably intended for oral administration.

[0095] According to yet another embodiment of the invention, the composition, for use as defined above, is more particularly characterized in that: the bacterial strain or bacteria Limosilactobacillus fermentumI-5777 and / or I-5778 is in dry form, preferably lyophilized, and is present in an amount ranging from 1x10⁷ to 1x10¹⁰ CFU, preferably from 2x10⁸ to 2x10⁹ CFU and, yeast Sc I-3856 is in dry form, and is present in an amount ranging from 1x10⁷ to 1x10¹¹ CFU, preferably from 1x10⁹ to 1x10¹² CFU, and even more preferably from 2.5x10⁹ to 5x10⁹ CFU.

[0096] According to another embodiment, the composition, for use as defined above, is more particularly characterized in that: the bacterial strain or bacteria Limosilactobacillus fermentum I-5777 and / or I-5778 is in dry form, preferably lyophilized, and is present in an amount ranging from 1x10⁷ to 1x10¹⁰ CFU, preferably from 2x10⁸ to 2x10⁹ CFU and, yeast Sc I-3856 is in dead yeast form, and is present in an amount ranging from 1 to 10,000 mg, and preferably from 100 to 1,000 mg.

[0097] According to yet another embodiment, the composition, for use as defined above, is more particularly characterized in that: the bacterial strain or bacteria Limosilactobacillus fermentum I-5777 and / or I-5778 is in dry form, preferably lyophilized, and is present in an amount ranging from 1x10⁷ to 1x10¹⁰ CFU, preferably from 2x10⁸ to 2x10⁹ CFU and, yeast Sc I-3856 is in yeast cell wall form, and is present in an amount ranging from 0.5 to 5,000 mg, preferably from 50 to 500 mg.

[0098] According to another embodiment, the composition, for use as defined above, is more particularly characterized in that: the bacterial strain or bacteria Limosilactobacillus fermentumI-5777 and / or I-5778 is in dry form, preferably lyophilized, and is present in an amount ranging from 1x10 7< to 1x10 10< CFU, preferably from 2x10 8< to 2x10 9< CFU and, yeast Sc I-3856 is in cell wall glucan form and is present in an amount ranging from 0.125 to 1250 mg, preferably from 12.5 to 125 mg.

[0099] According to another embodiment, the composition, for use as defined above, is more particularly characterized in that: the bacterial strain or bacteria Limosilactobacillus fermentum I-5777 and / or I-5778 is in dry form, preferably lyophilized, and is present in an amount ranging from 1x10 7< to 1x10 10< CFU, preferably from 2x10 8< to 2x10 9< CFU and, yeast Sc I-3856 is in cell wall mannoprotein form and is present in an amount ranging from 0.125 to 1250 mg, preferably from 12.5 to 125 mg. A brief description of the designs

[0100] Other features, details and advantages will become apparent upon reading the detailed description below, and upon analysis of the attached drawings. Fig. 1 [ Fig. 1 ] is a histogram resulting from an initial experiment and which shows the percentage of inhibition of hyphal formation of Candida albicans by lactobacilli designated "LS1" to "LS14", lactobacilli LS4 and LS5 corresponding to the bacterial strains of the invention, namely CNCM I-5777 and CNCM I-5778 strains respectively. The y-axis represents the percentage of hyphae formation normalized to Candida albicans. The "CA" group ( Candida albicans ) represents the control group. Significant differences compared to the control group are marked with an asterisk ** p<0.01. Fig. 2 [ Fig. 2 ] is a histogram resulting from a second experiment and which shows the percentage of inhibition of hyphal formation of Candida albicansby respectively the control CA and the lactobacilli LS4 (CNCM I-5777), LS5 (CNCM I-5778) and LS7. The y-axis represents the percentage of hyphae formation normalized to Candida albicans. Significant differences compared to the control group are marked with an asterisk **** p<0.0001. Fig. 3 [ Fig. 3 ] is a histogram resulting from a third experiment and which shows the percentage of inhibition of hyphal formation of Candida albicans by the control CA and the lactobacilli LS4 (CNCM I-5777) and LS5 (CNCM I-5778), respectively. The y-axis represents the percentage of hyphae formation normalized to Candida albicans. Significant differences compared to the control group are marked with an asterisk **** p<0.0001. Fig. 4 [ Fig. 4 ] is a histogram that shows the percentage of inhibition of hyphal formation of Candida albicans by respectively the CA control, alone or combined with Saccharomyces cerevisiaeCNCM I-3856 (“Sc”), and lactobacilli (LS4, LS7 and LS11) alone (light gray histograms) or in combination with Saccharomyces cerevisiae CNCM I-3856 (Sc) (hatched histograms). The y-axis represents the percentage of hyphae formation normalized to Candida albicans. "-Sc" signifies the absence of Saccharomyces cerevisiae while “+Sc” signifies the presence of Saccharomyces cerevisiae. Significant differences compared to the control group are marked with an asterisk **** p<0.0001. Description of the methods of realization

[0101] Example 1 below refers to Figures 1 to 4 . Example 1 Hyphae test

[0102] The hyphae test, carried out under conditions in vitro, allows us to evaluate the ability of strains (of bacteria or yeast) to block hyphae formation (i.e., to inhibit hyphae formation) of Candida albicans.

[0103] Indeed, hyphal formation is a crucial step in virulence and the ability to invade Candida albicans Hyphal morphogenesis is thus an important factor in the virulence of C. albicans.

[0104] Hyphal inhibition / reduction represents a promising approach to combat infections. White. Tested strains

[0105] Fourteen strains of lactobacilli were tested (LS1 to LS14), alone or in association with the S. strain. yeast CNCM I-3856.

[0106] Strains LS1 to LS14 are strains isolated from sourdough starter. LS1: Lactiplantibacillus plantarum, Identification reference BCC_002300, LS2: Lactiplantibacillus plantarum, Identification reference BCC_002377, LS3: Lactiplantibacillus plantarum, Identification reference BCC_003240, LS4: Limosilactobacillus fermentum, Identification reference BCC_002284 (strain filed with the CNCM on November 17, 2021 under number I-5777), LS5: Limosilactobacillus fermentum,Identification reference BCC_002321 (strain filed with the CNCM on November 17, 2021 under number I-5778), LS6: Lactobacillus paracasei, identification reference BCC_002365, LS7: Lactiplantibacillus plantarum, Identification reference BCC_002378 (strain filed with the CNCM on November 17, 2021 under number I-5779), LS8: Lactiplantibacillus plantarum, Identification reference BCC_004104, LS9: Lactiplantibacillus plantarum, Identification reference BCC_004132, LS10: Lactiplantibacillus plantarum, Identification reference BCC_004299, LS11: Lacticaseibacillus paracasei , identification reference BCC_002274, LS12: Lacticaseibacillus paracasei, Identification reference BCC_002301, LS13: Lacticaseibacillus paracasei, Identification reference BCC_003027, LS14: Lacticaseibacillus paracasei, Identification reference BCC_003258. Testing protocol Protocol with lactobacilli alone

[0107] The overnight culture concentrations of lactobacillus strains (LS1 to LS14) and strains of C. albicansare estimated by spectrophotometry (optical density at 600 nm). The cultures are then adjusted to a concentration of 1 x 10⁹ CFU / ml for lactobacilli and 1 x 10⁹ CFU / ml for other bacteria. 6< CFU / ml for C. albicans.

[0108] Mixtures of C. albicans with lactobacilli are carried out by adding 50 µl of suspension of each tested microorganism to 125 µl of fetal calf serum (FCS), supplemented with YPD broth (yeast extract peptone-dextrose broth) for a total volume of 500 µl.

[0109] For each condition, four technical replicates are included (the results come from 4 different wells but with the same initial overnight culture). After 3 hours of incubation at 37°C, 2 µl of the mixtures are used for microscopic evaluation by counting the number of yeast cells and the number of hyphae-forming cells. At least 100 cells are counted, and the ratios are calculated and normalized to the negative control (i.e., C. albicans + FCS). Protocol with lactobacilli in combination with Saccharomyces cerevisiae

[0110] The cultural survivor of a one-night stand S. cerevisiae (Sc I-3856) is obtained by centrifugation (10 min, 2000 g) and filtration (0.20µm cellulose acetate filter).

[0111] The concentrations of overnight cultures of lactobacillus strains and C. albicansare estimated by spectrophotometry (optical density at 600 nm). The cultures are then adjusted to a concentration of 1 x 10⁹ < CFU / ml for lactobacilli and 1 x 10⁶ < CFU / ml for C. albicans.

[0112] Mixtures of C. albicans with lactobacilli and the supernatant of S. cerevisiae are carried out by adding 50 µl of suspension of each tested microorganism to 125 µl of fetal calf serum (FCS), supplemented with YPD broth for a total volume of 500 µl.

[0113] The rest of the protocol is identical to the protocol described previously for lactobacilli alone. Results

[0114] The results obtained are discussed below and illustrated by the Figures 1 to 4 In each of these figures, zero percent (0%) inhibition of hyphae formation is observed with the CA control ( C. albicans (which means 100% hyphae formation) C. albicans ). Lactobacilli alone (Figures 1 to 3)

[0115] It emerges from the Figure 1 that, among the 14 lactobacilli tested (LS1 to LS14), only the strains Limosilactobacillus fermentum LS4 (CNCM I-5777) and LS5 (CNCM I-5778) allow strong inhibition of hyphal formation C. albicans.

[0116] Indeed, with strains LS4 and LS5, we observe approximately 72% inhibition of hyphal formation (i.e., approximately 28% hyphal formation) (LS4) and approximately 78% inhibition of hyphal formation, respectively. C. albicans (i.e., approximately 22% hyphae formation) (LS5).

[0117] In the Figure 2 LS4 (CNCM I-5777) and LS5 (CNCM I-5778) strains were compared to LS7 (CNCM I-5779) strain because this strain is representative of a large number of tested strains.

[0118] It also emerges from the Figure 2 that the LS4 (CNCM I-5777) and LS5 (CNCM I-5778) strains allow strong inhibition of hyphal formation C. albicanscompared to strain LS7 (CNCM I-5779). Indeed, with strains LS4 and LS5 we observe approximately 74% inhibition (LS4) and approximately 75% inhibition (LS5) respectively, while with strain LS7 (CNCM I-5779) the inhibition is barely 20%.

[0119] In the Figure 3 Only strains LS4 (CNCM I-5777) and LS5 (CNCM I-5778) were compared. Again, the results obtained are promising, as these strains lead to a strong inhibition of hyphal formation. C. albicans, namely approximately 81% (LS4) and 93% (LS5) inhibition of hyphal formation C. albicans. Lactobacilli in combination with Saccharomyces cerevisiae (Figure 4)

[0120] It emerges from the Figure 4 that the association of LS4 (CNCM I-5777) with S. cerevisiae CNCM I-3856 leads to an unexpected synergistic effect, which is not the case with the respective association of strains LS7 (CNCM I-5779) and LS11 with Sc I-3856.

[0121] Indeed, the use of the strain S. cerevisiae CNCM I-3856 (see "CA +Sc") alone (i.e., not associated with a lactobacillus) leads to inhibition of hyphal formation of C. albicans of approximately 9% under the experimental conditions used. The use of the LS4 strain alone (see "LS4-Sc") leads to an inhibition of hyphal formation of C. albicans of approximately 52%. However, when the LS4 and Sc CNCM I-3856 strains are combined, then the inhibition of hyphal formation of C. albicans is almost total since it is approximately 97%.

[0122] The present invention is not limited to the examples described above, which are given only by way of example, but encompasses all the variants that a person skilled in the art could consider within the scope of the protection sought, as defined in the claims. Reference to deposited biological material

[0123] This application refers to the following biological materials and derived variant or mutant strains: identification reference “BCC_002284” and registration number “I-5777” filed with the National Collection of Microorganism Cultures (CNCM) (25, rue du Docteur Roux, 75724 Paris cedex 15) in France, on November 17, 2021 by Lesaffre et Compagnie whose address is 41 rue Etienne Marcel, 75009 Paris; identification reference “BCC_002321” and registration number “I-5778” filed with the National Collection of Microorganism Cultures (CNCM) (25, rue du Docteur Roux, 75724 Paris cedex 15) in France, on November 17, 2021 by Lesaffre et Compagnie whose address is 41 rue Etienne Marcel, 75009 Paris; identification reference “BCC_002378” and registration number “I-5779” filed with the National Collection of Microorganism Cultures (CNCM) (25, rue du Docteur Roux, 75724 Paris cedex 15) in France, on November 17, 2021 by Lesaffre et Compagnie whose address is 41 rue Etienne Marcel, 75009 Paris;identification reference “SCPro-1” and registration number “I-3856” filed with the National Collection of Microorganism Cultures (CNCM) (25, rue du Docteur Roux, 75724 Paris cedex 15) in France, on October 17, 2007 by Lesaffre et Compagnie whose address is 41 rue Etienne Marcel, 75009 PARIS.;

Claims

1. Limosilactobacillus fermentum strain chosen among the strain deposited with the CNCM on November 17, 2021 under number I-5777 or under number 1-5778, for its use in the prevention and / or treatment of vaginal candidiasis.

2. Bacteria obtained by culturing the Limosilactobacillus fermentum strain chosen among the strain deposited with the CNCM on November 17, 2021 under number I-5777 or under number I-5778, for its use in the prevention and / or treatment of vaginal candidiasis.

3. Bacteria for use according to claim 2, characterized in that it is presented in frozen form or in dry form, preferably in dry form, and more preferably still in freeze-dried dry form.

4. Strain for use according to claim 1 or bacteria for use according to claim 2 or 3, wherein the vaginal candidiasis is due to fungi chosen from the group comprising Candida albicans, Candida tropicalis, Candida pseudotropicalis, Candida krusei, Candida glabrata, and mixtures thereof.

5. Strain or bacteria for use according to any one of claims 1 to 4, wherein it is used in association with the Saccharomyces cerevisiae strain deposited with the CNCM on October 17, 2007 under number I-3856 and / or with the yeast obtained by culturing said Saccharomyces cerevisiae strain.

6. Strain or bacteria for use according to claim 5, wherein the yeast obtained by culturing the Saccharomyces cerevisiae strain is in the form of dry yeast or fresh yeast, and preferably in the form of dry yeast.

7. Strain or bacteria for use according to claim 6, wherein the dry yeast is in the form of active dry yeast or instant dry yeast.

8. Strain or bacteria for use according to claim 5, wherein the yeast is in the form of inactive yeast.

9. Strain or bacteria for use according to claim 5, wherein the yeast is in the form of a yeast derivative, said derivative being chosen among the cell wall of said yeast, the cell wall glucans of said yeast, the cell wall mannoproteins of said yeast, or mixtures thereof.

10. Composition comprising: - a Limosilactobacillus fermentum strain chosen among the strain deposited with the CNCM on November 17, 2021 under number I-5777 or under number I-5778, and / or a bacteria obtained by culturing said Limosilactobacillus fermentum strain, - the Saccharomyces cerevisiae strain deposited with the CNCM on October 17, 2007 under number I-3856 and / or the yeast obtained by culturing said Saccharomyces cerevisiae strain, - possibly an excipient, for its use in the prevention and / or treatment of vaginal candidiasis.

11. Composition for use according to claim 10, wherein the composition is a pharmaceutical composition, a food composition, or a food supplement.

12. Composition for use according to claim 10 or claim 11, wherein it is in a form suitable for oral or vaginal administration, preferably oral.

13. Composition for use according to any one of claims 10 to 12, further comprising an active ingredient chosen from the group comprising vitamin K, vitamin B9, glutathione, S-adenosyl-L-methionine (SAM-e), chondroitin sulfate, and mixtures thereof.

14. Composition for use according to any one of claims 10 to 13, wherein: - Limosilactobacillus fermentum bacterial strain or bacteria I-5777 and / or I-5778 is in dry form, preferably freeze-dried, and is present in a quantity ranging from 1x107 to 1x1010 CFU, preferably from 2x108 to 2x109 CFU, and - yeast Sc 1-3856 is in dry form, and is present in a quantity ranging from 1x107 to 1x1011 CFU, preferably from 1x109 to 1x1010 CFU, and even more preferably from 2.5x109 to 5x109 CFU.