Compositions for improving quality of life

Abstract

The present invention addresses the problem of providing a technology for improving quality of life (QOL), preferably, to provide a technology for ameliorating insomnia, for ameliorating fatigue, or for improving gastrointestinal regulation. This problem is solved by a composition for improving QOL, which contains Lactobacillus helveticus.

Description

[Technical field]

[0001] The present invention relates to a composition for improving QOL. [Background technology]

[0002] In recent years, an index called QOL (Quality of Life), which can be translated as "quality of life," has come into use. QOL generally refers to the quality of the content of an individual's life, or the "quality of life" seen from a social perspective, and can be said to be a concept that measures how much a person lives a human and individual-like life and finds happiness in life. Therefore, QOL is closely related to each individual's daily life, and can be said to be closely related to, for example, an individual's daily sleep, fatigue, intestinal function, etc.

[0003] Sleep is an important physiological function for higher animals such as humans. In recent years, many people are unable to get enough quality sleep due to lifestyle changes that disrupt their daily rhythms, resulting in daytime functional disorders such as work and school, and are suffering from insomnia. In response to this, various insomnia improvers and sleep improvers have been developed. For example, it has been reported that a human who ingested a lactic acid bacterium containing Lactobacillus helveticus LBH MIKI-020 (FERM P-13678), a fermented product of the lactic acid bacterium, and a compound containing a disrupted cell of the lactic acid bacterium for 4 weeks was evaluated for sleep using the OSA Sleep Questionnaire MA version, and that significant improvements were observed in factor I (sleep upon waking) and factor II (sleep onset and sleep maintenance) after the end of the test (4 weeks) compared to before the start of the test (0 weeks) (Patent Document 1).

[0004] In recent years, many people have been feeling mental and physical fatigue caused by work and other activities. One of the causes of mental (central) fatigue is an increase in the concentration of serotonin in the brain, and when the balance of amino acids in the blood is disrupted by exercise or stress, the concentration of serotonin in the brain increases. In general, taking sufficient rest is effective in improving mental and physical fatigue, but various nutritional drinks and supplements have been developed for people who cannot take sufficient rest. For example, it has been reported that a person who took tablets containing soybean saponin group B for 8 weeks was evaluated using a VAS and found that fatigue, expressed numerically in the following categories, was significantly improved (Patent Document 2). In addition, it has been reported that when a soft drink containing gamma-aminobutyric acid (GABA) was obtained by fermenting a specified fermentation material using Lactobacillus hilgardii K-3 (FERM P-18422), heat-sterilizing the fermented liquid, filtering it, and spray-drying the resulting filtrate, a human ingested the drink 30 minutes before starting exercise, and that after exercise, the increase in the "fatigue" score evaluated by POMS and the increase in brain serotonin concentration were suppressed (Patent Document 3).

[0005] In recent years, many people are experiencing poor intestinal function due to unhealthy lifestyles such as irregular lifestyles and lack of exercise, hormonal imbalances, and mental stress. In response to this, various foods and medicines that have an intestinal regulating effect have been developed. For example, it has been reported that a person who orally took three tablets a day containing killed Lactobacillus brevis bacteria and lactoferrin as active ingredients from after dinner to before going to bed for four weeks had an increased number of bowel movements and amount of stool in one week, resulting in an excellent improvement of the intestinal environment (Patent Document 4).

[0006] On the other hand, a bacterium called Lactobacillus helveticus is known. Lactobacillus helveticus is known to secrete D-amino acids with high efficiency, and a method for producing D-amino acids with high efficiency using the bacterium has been developed (Patent Document 5).

[0007] However, it is not known that Lactobacillus helveticus has the effect of improving quality of life. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] JP 2016-104802 A [Patent Document 2] JP 2012-31132 A [Patent Document 3] JP 2006-273733 A [Patent Document 4] US Patent Application Publication No. 2011 / 0123576 [Patent Document 5] JP 2015-047114 A Summary of the Invention [Problem to be solved by the invention]

[0009] The present invention has been made in view of the above circumstances, and an objective of the present invention is to provide a technique for improving quality of life (QOL), preferably a technique for improving insomnia, fatigue, or intestinal regulation. [Means for solving the problem]

[0010] The present inventors have found that Lactobacillus helveticus has a QOL improving effect, preferably an insomnia improving effect, a fatigue improving effect, and an intestinal regulating effect, and have thus completed the present invention.

[0011] The present invention can provide a composition for improving QOL, comprising Lactobacillus helveticus.

[0012] The present invention can also provide a composition for improving insomnia, comprising Lactobacillus helveticus. In a preferred embodiment of the composition, the insomnia is insomnia expressed by the total score of items evaluated according to the Athens Insomnia Scale.

[0013] The present invention can also provide a composition for improving fatigue, comprising Lactobacillus helveticus. In a preferred embodiment of the composition, the fatigue is one or more selected from the group consisting of the following (1) to (5). (1) Fatigue, as measured by the POMS (registered trademark) item “Fatigue” (2) Fatigue, as measured by the POMS2™ item “Fatigue-Lethargy” (3) Fatigue, as measured by the VAS (feeling fatigued) (4) Fatigue, as measured by the VAS score of “feeling exhausted” (5) Fatigue, as expressed by the sum of the items assessed by the CFS

[0014] The present invention can also provide a composition for intestinal regulation, comprising Lactobacillus helveticus.

[0015] In any of the above compositions, the Lactobacillus helveticus is preferably Lactobacillus helveticus MCC1848 (NITE BP-01671). In addition, in a preferred embodiment, each of the above compositions is a food or drink composition. In addition, in a preferred embodiment, each of the above compositions is a pharmaceutical composition. Effect of the Invention

[0016] According to the present invention, a technique for improving QOL can be provided. Preferably, a technique for improving insomnia, fatigue, or intestinal regulation can be provided. Since Lactobacillus helveticus is a bacterium that can be contained in foods, beverages, and medicines, it can be prepared as foods, beverages, and medicines to improve QOL, and can be easily ingested by subjects. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] The present invention will be described in detail below. However, the present invention is not limited to the following embodiments and can be freely modified within the scope of the present invention.

[0018] The present invention will be described in detail below. Furthermore, the composition for improving QOL containing Lactobacillus helveticus according to the present invention, as well as the preferred embodiments thereof, such as the composition for improving insomnia, the composition for improving fatigue, and the composition for regulating the intestines, may all be mixtures, regardless of whether the components are homogeneous or heterogeneous. In addition, in this specification, the composition for improving QOL according to the present invention, as well as the composition for improving insomnia, the composition for improving fatigue, and the composition for regulating the intestines, which are also preferred embodiments, may be collectively referred to as the "composition of the present invention." Furthermore, the composition of the present invention may contain Lactobacillus helveticus alone, or may contain other ingredients as long as they exert a QOL improving effect. Additionally, in this specification, the terms "ingestion," "ingest," and "ingested," when used in reference to pharmaceutical compositions, can be replaced with the terms "administration," "administered," and "administered," respectively.

[0019] The composition of the present invention contains Lactobacillus helveticus. The Lactobacillus helveticus used in the present invention is not particularly limited as long as it exerts a QOL improving effect, and in a preferred embodiment, an insomnia improving effect, a fatigue improving effect, or an intestinal regulation effect when a subject ingests a composition containing Lactobacillus helveticus. For example, Lactobacillus helveticus MCC1848 (NITE BP-01671), Lactobacillus helveticus JCM 1120 (JCM 1120 TIt may be written as "T". T stands for standard strain. ), Lactobacillus helveticus DSM 20075, Lactobacillus helveticus SBT 2171, etc. are included. Preferably, Lactobacillus helveticus MCC1848 (NITE BP-01671). In the composition of the present invention, one or more Lactobacillus helveticus may be used.

[0020] Lactobacillus helveticus MCC1848 (NITE BP-01671) was deposited on July 29, 2013 at the Patent Microorganisms Depositary Center, National Institute of Technology and Evaluation (Room 122, 2-5-8 Kazusa Kamatari, Kisarazu City, Chiba Prefecture, 292-0818) under the Budapest Treaty (accession number: NITE BP-01671). Lactobacillus helveticus JCM 1120 is available from the RIKEN BioResource Center, Microbial Materials Division (JCM). Lactobacillus helveticus DSM 20075 is available from Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, Inhoffenstraβe 7B, 38124 Braunschweig, Germany. Lactobacillus helveticus SBT 2171 is available from MEGMILK Snow Brand Co., Ltd.

[0021] In addition, Lactobacillus helveticus MCC1848 (NITE BP-01671) is not limited to the strain deposited or registered with a designated institution under the name of the bacterium (hereinafter, for convenience of explanation, also referred to as the "deposited strain"), but also includes strains that are substantially equivalent thereto (also referred to as "derived strains" or "derived strains"). In other words, "Lactobacillus helveticus MCC1848 (NITE BP-01671)" is not limited to the strain deposited with the above depository institution under the accession number NITE BP-01671, but also includes strains that are substantially equivalent thereto. The term "strain substantially equivalent to the deposited strain" refers to a strain that belongs to the same species as the deposited strain, that can obtain the effects of the present invention, that has an identity of preferably 98% or more, more preferably 99% or more, and even more preferably 100% in the nucleotide sequence of its 16SrRNA gene to the nucleotide sequence of the 16SrRNA gene of the deposited strain, and that preferably has the same mycological properties as the deposited strain. The strain substantially equivalent to the deposited strain may be, for example, a derived strain having the deposited strain as a parent strain. Derived strains include strains bred from the deposited strain and strains that have naturally arisen from the deposited strain. Breeding methods include modification by genetic engineering techniques and modification by mutation treatment. Mutation treatments include irradiation with X-rays, irradiation with ultraviolet rays, and treatment with mutagens such as N-methyl-N'-nitro-N-nitrosoguanidine, ethyl methanesulfonate, and methyl methanesulfonate. Strains that have naturally arisen from the deposited strain include strains that have naturally arisen during use of the deposited strain. Such strains include mutants that have arisen naturally upon culturing (e.g., subculturing) the deposited strain. Derivative strains may be constructed by a single modification, or by two or more modifications. This also applies to the other deposited strains mentioned above.

[0022] The Lactobacillus helveticus cells that can be contained in the composition of the present invention may be commercially available or may be obtained by appropriate production. For example, a commercially available heat-sterilized Lactobacillus helveticus MCC1848 (NITE BP-01671) product can be obtained from Morinaga Milk Industry Co., Ltd.

[0023] Lactobacillus helveticus that can be contained in the composition of the present invention can be easily obtained by culturing Lactobacillus helveticus. The culturing method is not particularly limited as long as Lactobacillus helveticus can grow. As the culturing method, for example, a method commonly used for culturing Lactobacillus bacteria (lactic acid bacteria) can be used as is or with appropriate modification. The culture temperature may be, for example, 25 to 50°C, and preferably 35 to 42°C. The culture can be preferably carried out under anaerobic conditions, for example, while aerating anaerobic gas such as carbon dioxide gas. The culture can also be carried out under microaerobic conditions such as liquid stationary culture. The culture can be carried out, for example, until Lactobacillus helveticus grows to a desired extent.

[0024] The medium used for the culture is not particularly limited as long as Lactobacillus helveticus can grow. As the medium, for example, a medium usually used for culturing Lactobacillus bacteria can be used as it is or after appropriate modification. That is, as the carbon source, for example, sugars such as galactose, glucose, fructose, mannose, cellobiose, maltose, lactose, sucrose, trehalose, starch, starch hydrolysate, blackstrap molasses, etc. can be used according to assimilation. As the nitrogen source, for example, ammonium salts such as ammonia, ammonium sulfate, ammonium chloride, ammonium nitrate, and nitrates can be used. In addition, as the inorganic salt, for example, sodium chloride, potassium chloride, potassium phosphate, magnesium sulfate, calcium chloride, calcium nitrate, manganese chloride, ferrous sulfate, etc. can be used. In addition, organic components such as peptone, soybean flour, defatted soybean meal, meat extract, yeast extract, etc. may be used. Specific examples of media commonly used for culturing Lactobacillus bacteria include Reinforced Clostridial medium, de Man, Rogosa, and Sharpe medium (MRS medium), modified MRS medium (mMRS medium), TOS propionate medium (TOSP medium), and TOS propionate mupirocin medium (TOSP Mup medium).

[0025] As the Lactobacillus helveticus that can be contained in the composition of the present invention, Lactobacillus helveticus cells or fractions containing the same can be used without any particular limitation. That is, as the Lactobacillus helveticus, for example, the culture obtained by culturing may be used as it is, the culture may be diluted or concentrated, or the cells recovered from the culture may be used. In addition, various additional operations such as heating and freeze-drying can be performed after culturing, as long as the effect of the present invention is not impaired. That is, as the Lactobacillus helveticus that can be contained in the composition of the present invention, specifically, the culture of Lactobacillus helveticus, the cells recovered from the culture, and their processed products can be mentioned, and the processed products can be mentioned as diluted products, concentrated products, dried products, etc.

[0026] The bacterial cells may be live or dead, and are preferably used in a form containing dead cells. If the bacterial cells are live, they can be expected to have a probiotic effect. The bacterial cells may be live or dead, or may be a mixture of live and dead cells. Examples of killed bacteria include killed bacteria sterilized by heating, etc. (i.e., heat-sterilized bacteria, etc.). Heat-sterilized bacteria can be obtained, for example, by culturing Lactobacillus helveticus as described above, centrifuging the resulting culture solution, lyophilizing it to obtain live bacteria powder, suspending it in sterilized water, and heat-sterilizing it at 90°C for 30 minutes. Other methods for preparing killed bacteria include spray drying, retort sterilization, freeze-drying, UHT sterilization, pressure sterilization, high-pressure steam sterilization, dry heat sterilization, circulating steam disinfection, electromagnetic wave sterilization, electron beam sterilization, high frequency sterilization, radiation sterilization, ultraviolet sterilization, ethylene oxide gas sterilization, hydrogen peroxide gas plasma sterilization, and chemical sterilization (alcohol sterilization, formalin fixation, electrolyzed water treatment), etc.

[0027] The subject of taking the composition of the present invention is a human. The human may be male or female, but is preferably female. The human is preferably 20 years or older and younger than 65 years old. The value of the item FI (fatigue-lethargy) evaluated by the POMS2 short version of the human is preferably 50 or more, more preferably 55 or more, even more preferably 60 or more, and is preferably 75 or less, more preferably 73 or less, even more preferably 70 or less. The human whose item FI (fatigue-lethargy) value is within the above-mentioned range in both of the two identical evaluations is more preferable.

[0028] QOL in the present invention includes, for example, the degree of sleep health, the degree of physical health, etc. Improving the degree of sleep health includes, for example, improving the degree of insomnia of the subject. Improving the degree of physical health includes, for example, improving the degree of fatigue of the subject, improving the degree of intestinal function of the subject, etc. The Lactobacillus helveticus contained in the composition of the present invention has the effect of improving insomnia, fatigue, and intestinal function of a subject. Therefore, the composition of the present invention is also useful as a composition for improving insomnia, a composition for improving fatigue, and a composition for improving intestinal function (a composition for improving intestinal function may be called a composition for intestinal regulation).

[0029] One aspect of the present invention is a composition for improving insomnia, comprising the Lactobacillus helveticus. Hereinafter, the composition may be referred to as "composition of aspect 1."

[0030] The Lactobacillus helveticus contained in the composition of embodiment 1 has an insomnia improving effect. That is, for example, when a subject takes Lactobacillus helveticus, insomnia is improved more than when the subject does not take it (or before taking it, or when the subject takes a placebo). Therefore, the Lactobacillus helveticus can be used as an active ingredient of a composition for improving insomnia. In addition, the insomnia of the subject who takes the composition containing Lactobacillus helveticus is improved compared to the subject who takes the composition not containing Lactobacillus helveticus. That is, the insomnia may be evaluated as being improved compared to the insomnia of the subject who takes the composition not containing Lactobacillus helveticus (e.g., placebo). In addition, the insomnia of the subject who takes the composition not containing Lactobacillus helveticus may or may not be improved.

[0031] The insomnia improved by this embodiment is not particularly limited as long as it is improved when the subject ingests Lactobacillus helveticus, but is preferably one or more selected from the group consisting of "a state in which it takes a long time from going to bed to actually falling asleep", "a state in which the subject wakes up during sleep at night", "a state in which the subject wakes up earlier than the desired wake-up time and is unable to fall asleep thereafter", "a state in which the duration of sleep is insufficient, including nighttime sleep and daytime naps", "a state in which the subject is not satisfied with the overall quality of sleep", "a state of feeling depressed during the day", "a state in which the state of physical and mental activity during the day is reduced", "a state of daytime sleepiness", "a state in which the subject feels sleepy or fatigued when waking up and is unable to wake up refreshed", and "a state in which the subject's sleep state is poor". The use of this embodiment may also be to improve the quality of sleep and / or the quality of awakening.

[0032] The insomnia improved by the present invention may be subjective insomnia, insomnia that can be objectively determined by tests commonly performed in the art, or insomnia that can be determined by questionnaires commonly performed in the art, but preferably insomnia that can be objectively determined by tests commonly performed in the art or insomnia that can be determined by questionnaires commonly performed in the art.

[0033] When the insomnia improved by this embodiment is insomnia that can be objectively determined by a test commonly performed in the art, it can be, for example, insomnia expressed by the total score of items evaluated by the Athens Insomnia Scale (AIS). The insomnia improved by this embodiment may be insomnia that can be objectively determined by one test, or insomnia that can be objectively determined by multiple tests. Preferably, it is insomnia that can be expressed by the total score of items evaluated by the Athens Insomnia Scale.

[0034] The Athens Insomnia Scale is a test created by the World Health Organization (WHO)-led Global Project on Sleep and Health, and is widely used in the technical field. As is well known, the Athens Insomnia Scale is a test in which subjects answer the following items on a four-point scale (0, 1, 2, 3 points) for at least three times a week in the past month: "Taking a long time from going to bed to actually falling asleep", "Waking up in the middle of sleep at night", "Waking up earlier than the desired wake-up time and not being able to fall asleep after that", "Not enough sleep time, including nighttime sleep and daytime naps", "Not satisfied with the overall quality of sleep", "Feeling depressed during the day", "Decline in physical and mental activity during the day", and "Feeling sleepy during the day". The total score is used to determine whether the subject has experienced these items at least three times a week in the past month. In a test using the Athens Insomnia Scale, a total score of 3 or less is considered to be "good sleep," 4-5 points is considered to be "slightly suspicious of insomnia," and 6 points or more is considered to be "highly suspicious of insomnia."

[0035] When the insomnia improved by this embodiment is insomnia represented by the total score of items evaluated by the Athens Insomnia Scale, the total score when the subject takes the composition of embodiment 1 is preferably reduced by 2 or more, more preferably by 5 or more, and even more preferably by 7 or more, based on the total score when the subject does not take the composition of embodiment 1 (or before taking it, or when taking a placebo). On the other hand, it is preferable that the total score is reduced by, for example, 20 or less.

[0036] In this case, the total score when the subject does not take the composition of embodiment 1 (or before taking it, or when taking a placebo) is not particularly limited, but is preferably 4 or more, more preferably 5 or more, and even more preferably 6 or more, while it is preferably 20 or less, more preferably 17 or less, and even more preferably 15 or less.

[0037] Furthermore, when the use of this embodiment is to improve sleep quality and / or ease of awakening, and the improvement is evaluated by the questionnaire item "quality of sleep / ease of awakening," it is preferable that the number of people who answered "better" or "slightly improved" in "quality of sleep / ease of awakening" when the subject takes the composition of embodiment 1, relative to the "quality of sleep / ease of awakening" when the subject does not take the composition of embodiment 1 (or before taking it, or when taking a placebo), is greater than the number of people who answered "unchanged," "slightly worse," or "worse," and more preferably is significantly greater.

[0038] The composition of the first aspect has an insomnia improving effect, and can be used for the prevention or treatment of diseases, symptoms, symptoms, disorders, etc. that can be prevented or treated by improving insomnia. In addition, "treatment" also includes improvement. In addition, the subject may have one or more diseases, symptoms, symptoms, disorders, etc. Examples of such diseases, symptoms, conditions, or disorders include sleep disorders (e.g., insomnia, hypersomnia (e.g., narcolepsy, etc.), parasomnia, delayed sleep phase syndrome (sometimes referred to as delayed sleep phase disorder), etc.). Insomnia is a chronic condition characterized by symptoms such as difficulty falling asleep, frequent awakenings, and shallow sleep. Hypersomnia is a condition in which excessive daytime sleepiness interferes with daily life. Narcolepsy is a symptom in which a person is overcome by intolerable daytime sleepiness and suddenly falls asleep, and is a type of hypersomnia. Parasomnia is a general term for behavioral and mental and physical abnormalities that occur during sleep, and is a symptom commonly known as "sleepwalking." Delayed sleep phase syndrome is a condition in which a person leads a nocturnal lifestyle and is unable to wake up in the morning.

[0039] Another aspect of the present invention is a composition for improving fatigue, comprising the Lactobacillus helveticus. Hereinafter, the composition may be referred to as "composition of aspect 2."

[0040] The Lactobacillus helveticus contained in the composition of embodiment 2 has a fatigue improving effect. That is, for example, when a subject takes Lactobacillus helveticus, fatigue is improved more than when the subject does not take it (or before taking it, or when the subject takes a placebo). Therefore, the Lactobacillus helveticus can be used as an active ingredient of a composition for improving fatigue. In addition, fatigue is improved in subjects who take a composition containing Lactobacillus helveticus compared to subjects who take a composition that does not contain Lactobacillus helveticus. That is, the fatigue may be evaluated as being improved compared to the fatigue of subjects who take a composition that does not contain Lactobacillus helveticus (e.g., placebo). In addition, fatigue of subjects who take a composition that does not contain Lactobacillus helveticus may or may not be improved.

[0041] The fatigue improved by this embodiment is not particularly limited as long as it is improved when the subject takes Lactobacillus helveticus, but "fatigue and / or lethargy" is preferred. Also preferred are one or more selected from the group consisting of "being exhausted," "being worn out," "being worn out," "being tired," "being fed up," and "being exhausted." Also preferred are one or more selected from the group consisting of "feeling fatigued" and "being exhausted." Also preferred are one or more selected from the group consisting of "having problems with fatigue", "needing more rest", "feeling sleepy or sluggish", "having difficulty starting something", "starting something without problems, but becoming weaker as you continue", "lacking motivation", "having weaker muscles than before", "feeling physically weak", "having difficulty concentrating", "having difficulty thinking clearly", "making mistakes while speaking", "having difficulty finding the right words", "having worse memory than usual", and "having lost interest in things that you were previously interested in". The use of this embodiment may also be to improve fatigue and / or sluggishness.

[0042] The fatigue improved by this embodiment may be subjective fatigue, or may be fatigue that can be objectively determined by tests commonly performed in the relevant technical field, or may be fatigue that can be determined by questionnaires commonly performed in the relevant technical field, but is preferably fatigue that can be objectively determined by tests commonly performed in the relevant technical field or fatigue that can be determined by questionnaires commonly performed in the relevant technical field.

[0043] When the fatigue improved by this embodiment is fatigue that can be objectively determined by a test normally performed in the technical field, for example, fatigue represented by the numerical value of the item "fatigue" evaluated by POMS, fatigue represented by the numerical value of the item "fatigue-lethargy" evaluated by POMS2, fatigue represented by the numerical value of the item "feeling tired" evaluated by VAS, fatigue represented by the numerical value of the item "feeling exhausted" evaluated by VAS, fatigue represented by the total score of the items evaluated by CFS, etc. can be mentioned. The fatigue improved by this embodiment may be fatigue that can be objectively determined by one test, or may be fatigue that can be objectively determined by multiple tests. Preferably, it is one or more selected from the group consisting of fatigue represented by the numerical value of the item "fatigue" evaluated by POMS, fatigue represented by the numerical value of the item "fatigue-lethargy" evaluated by POMS2, fatigue represented by the numerical value of the item "feeling tired" evaluated by VAS, fatigue represented by the numerical value of the item "feeling exhausted" evaluated by VAS, and fatigue represented by the total score of the items evaluated by CFS.

[0044] POMS (registered trademark) and POMS2 (trademark) are respectively an abbreviation of Profile of Mood States and Profile of Mood States 2nd Edition, provided by Multi-Health Systems Inc., and are widely used tests in the technical field. POMS2 is a revised version of POMS, and its main parts have not been changed from the POMS. Note that POMS and POMS2 have different test methods depending on the target population, such as for adults and adolescents, and different numbers of questions during the test, such as full-item versions and shortened versions, but the test method and number of questions can be appropriately selected depending on the situation of the subject. As is well known, the test using POMS2 for "feeling exhausted" involves subjects answering the item "feeling exhausted" on a four-point scale of 0, 1, 2, or 3, and the degree of "feeling exhausted" is judged based on a score calculated using a prescribed method. The same applies to "feeling tired," "exhausted," "lazy," "fed up," and "exhausted." As is well known, the test for "fatigue and / or lethargy" using POMS2 involves subjects answering questions on a four-point scale (0, 1, 2, or 3) about the items "feeling exhausted," "feeling tired," "feeling worn out," "feeling fed up," and "feeling completely exhausted," and the subject's condition is judged based on a "Fatigue-Lethargy (FI)" score calculated using a prescribed method.

[0045] VAS is an abbreviation for Visual Analogue Scale, and is a test that is widely used in the technical field. As is well known, a test using VAS for "feeling fatigued" is a test in which the subject indicates where their current fatigue is on a 10 cm line, with "0" being "not feeling fatigued at all" and "100" being "feeling extremely fatigued" (feeling the most fatigue they have ever experienced). The same applies to "feeling exhausted."

[0046] CFS is an abbreviation of Chalder Fatigue Scale, and is a test that is widely used in the technical field and is recommended by the Centers for Disease Control and Prevention (CDC) for testing fatigue.As is well known, the test using CFS is a test that subjects answer the following items on a four-point scale (0, 1, 2, 3): "having problems with fatigue", "needing more rest", "feeling sleepy or sluggish", "having difficulty starting something", "even if I start something without any problems, my body weakens as I continue doing it", "lack of motivation", "feeling weaker than before", "having difficulty concentrating", "having difficulty thinking clearly", "making mistakes when speaking", "having difficulty finding the right words", "having worse memory than usual", and "not being interested in things that I used to be interested in".

[0047] When the fatigue improved by this embodiment is fatigue represented by the numerical value of the item "Fatigue-Apathy" evaluated by POMS2, the numerical value of the item "Fatigue-Apathy" when the subject ingests the composition of embodiment 2 is preferably reduced by 2 or more, more preferably by 4 or more, and even more preferably by 8 or more, based on the numerical value of the item "Fatigue-Apathy" when the subject does not ingest the composition of embodiment 2 (or before ingesting it, or when ingesting a placebo). On the other hand, a reduction of, for example, 20 or less is preferable.

[0048] In this case, the numerical value of the item "Fatigue-Lethargy" when the subject does not take the composition of embodiment 2 (or before taking it, or when taking a placebo) is not particularly limited, but is preferably 50 or more, more preferably 55 or more, and even more preferably 60 or more, while it is preferably 75 or less, more preferably 73 or less, and even more preferably 70 or less.

[0049] When the fatigue improved by this embodiment is fatigue represented by the numerical value of the item "feeling fatigued" evaluated by VAS, the numerical value of the item "feeling fatigued" when the subject ingests the composition of embodiment 2 is preferably reduced by 5 or more, more preferably by 10 or more, and even more preferably by 15 or more, based on the numerical value of the item "feeling fatigued" when the subject does not ingest the composition of embodiment 2 (or before ingesting it, or when ingesting a placebo). On the other hand, a reduction of, for example, 80 or less is preferable.

[0050] In this case, the numerical value of the item "feeling fatigued" when the subject does not take the composition of embodiment 2 (or before taking it, or when taking a placebo) is not particularly limited, but is preferably 50 or more, more preferably 55 or more, and even more preferably 60 or more, while it is preferably 95 or less, more preferably 90 or less, and even more preferably 85 or less.

[0051] When the fatigue improved by this embodiment is fatigue represented by the numerical value of the item "feeling exhausted" evaluated by VAS, the numerical value of the item "feeling exhausted" when the subject ingests the composition of embodiment 2 is preferably reduced by 5 or more, more preferably by 10 or more, and even more preferably by 15 or more, based on the numerical value of the item "feeling exhausted" when the subject does not ingest the composition of embodiment 2 (or before ingesting it, or when ingesting a placebo). On the other hand, a reduction of, for example, 80 or less is preferable.

[0052] In this case, the numerical value of the item "feeling lethargic" when the subject does not ingest the composition of embodiment 2 (or before ingesting it, or when ingesting a placebo) is not particularly limited, but is preferably 50 or more, more preferably 55 or more, and even more preferably 60 or more, while it is preferably 95 or less, more preferably 90 or less, and even more preferably 85 or less.

[0053] When the fatigue improved by this embodiment is fatigue represented by the total score of items evaluated by CFS, the total score of the item when the subject takes the composition of embodiment 2 is preferably reduced by 2 or more, more preferably by 4 or more, and even more preferably by 6 or more, based on the total score of the item when the subject does not take the composition of embodiment 2 (or before taking it, or when taking a placebo). On the other hand, a reduction of, for example, 30 or less is preferable.

[0054] In this case, the total score when the subject does not take the composition of embodiment 2 (or before taking it, or when taking a placebo) is not particularly limited, but is preferably 10 or more, more preferably 15 or more, and even more preferably 20 or more, while it is preferably 40 or less, more preferably 35 or less, and even more preferably 30 or less.

[0055] Furthermore, when the use of this embodiment is to improve fatigue and / or body fatigue, and the improvement is evaluated by the questionnaire item "fatigue and body fatigue," it is preferable that the number of people who answered "better" or "slightly improved" in "fatigue and body fatigue" when the subject ingests the composition of embodiment 2, relative to the "fatigue and body fatigue" when the subject does not ingest the composition of embodiment 2 (or before ingesting it, or when ingesting a placebo), is greater than the number of people who answered "unchanged," "slightly worse," or "worse," and more preferably is significantly greater.

[0056] The composition of the second aspect has a fatigue improving effect, and can be used for the prevention or treatment of diseases, symptoms, symptoms, disorders, etc. that can be prevented or treated by improving fatigue. In addition, "treatment" also includes improvement. In addition, the subject may have one or more diseases, symptoms, symptoms, disorders, etc. Examples of such diseases, symptoms, disorders, etc. include decreased thinking ability, decreased response to stimuli, decreased attention, distractibility, slow movement, decreased activity, blurred vision, headache, stiff shoulders, lower back pain, etc.

[0057] Another aspect of the present invention is a composition for intestinal regulation, comprising the Lactobacillus helveticus. Hereinafter, this composition may be referred to as the "composition of aspect 3."

[0058] The Lactobacillus helveticus contained in the composition of embodiment 3 has an intestinal regulation effect. In this embodiment, the intestinal regulation effect refers to the effect of improving intestinal function. That is, when a subject takes Lactobacillus helveticus, the intestinal function is improved compared to when the subject does not take it (or before taking it, or when taking a placebo). Therefore, the Lactobacillus helveticus can be used as an active ingredient of a composition for intestinal regulation and as an active ingredient of a composition for improving intestinal function. In addition, the intestinal function of the subject who ingests the composition containing Lactobacillus helveticus is improved compared to the subject who ingests the composition not containing Lactobacillus helveticus. That is, the intestinal function may be evaluated as being improved compared to the intestinal function of the subject who ingests the composition not containing Lactobacillus helveticus (e.g., placebo). In addition, the intestinal function of the subject who ingests the composition not containing Lactobacillus helveticus may or may not be improved.

[0059] The intestinal function improved by this embodiment is not particularly limited as long as it is an intestinal function improved when a subject takes Lactobacillus helveticus. In addition, the use of this embodiment may be to improve stomach condition.

[0060] The intestinal function improved by this embodiment may be subjective intestinal function, or it may be intestinal function that can be objectively determined by tests commonly performed in the art, or it may be intestinal function that can be determined by questionnaires commonly performed in the art, but is preferably intestinal function that can be determined by questionnaires.

[0061] Furthermore, when the use of this embodiment is to improve stomach condition, and the improvement is evaluated by the "stomach condition" item in a questionnaire, it is preferable that the number of people who answered "better" or "slightly better" to the "stomach condition" when the subject ingests the composition of embodiment 3, relative to the "stomach condition" when the subject does not ingest the composition of embodiment 3 (or before ingesting it, or when ingesting a placebo), is greater than the number of people who answered "unchanged," "slightly worse," or "worse," and more preferably is significantly greater.

[0062] The composition of the third aspect has an intestinal regulating effect and can be used for the prevention or treatment of diseases, symptoms, symptoms, disorders, etc. that can be prevented or treated by intestinal regulation. In addition, "treatment" also includes improvement. In addition, the subject may have one or more diseases, symptoms, symptoms, disorders, etc. Such diseases, symptoms, conditions, disorders, etc. include, for example, defecation disorders. Defecation disorders include, for example, constipation, diarrhea, etc. In this specification, diarrhea includes fecal incontinence. Constipation is a disorder that refers to a state in which defecation is difficult, and examples of this include hard stools, difficulty in defecation, not having a bowel movement for several days, and the frequency and / or amount of defecation is small. Diarrhea is a disorder in which stool that is very loose, gel-like (porridge-like) or liquid compared to healthy stool is excreted. It is called loose stool, muddy stool, watery stool, etc., and the frequency and / or amount of stool excreted is large. Fecal incontinence is a disorder in which a person defecates unconsciously or against his will, and is characterized by a large number of defecations and / or a large amount of stool. Examples of fecal incontinence include stress fecal incontinence, urge fecal incontinence, overflow fecal incontinence, and functional fecal incontinence.

[0063] Specific examples of constipation and diarrhea include constipation or diarrhea caused by irritable bowel syndrome, pelvic floor dysfunction, congenital gastrointestinal dysfunction, intestinal obstruction, colon tumor, metabolic disease, central nervous system disease, peripheral nervous system disease, systemic disease, etc. Examples of intestinal obstruction include intestinal paralytic ileus, etc. Specific examples of diarrhea further include diarrhea caused by food poisoning, infectious enteritis, ulcerative colitis, food allergy, etc. Examples of constipation include slow-transit constipation, functional constipation, organic constipation, and drug-induced constipation.

[0064] The content of the Lactobacillus helveticus in the composition of the present invention is appropriately set depending on the form of the composition, but the total amount is 1 × 10 4 ~1×10 13 cfu / g or 1×10 4 ~1×10 13 cfu / ml, preferably in the range of 1×10 5 ~1×10 12 cfu / g or 1×10 5 ~1×10 12 More preferably, the range is 1×10 6 ~1×10 11 cfu / g or 1×10 6 ~1×10 11 More preferably in the range of cfu / ml. In the present specification, "cfu" stands for colony forming unit. In addition, in the present specification, when the Lactobacillus helveticus is a killed bacterium, cfu / g or cfu / ml can be replaced with individual cells / g or individual cells / ml.

[0065] The amount of intake of the composition of the present invention is appropriately determined depending on the form of the composition, the method of use, the subject, the age and sex of the subject, and other conditions, but is not particularly limited as long as it exerts a QOL improving effect, and in a preferred embodiment, an insomnia improving effect, a fatigue improving effect, or an intestinal regulation effect in the subject who takes it. 4~1×10 13 cfu, preferably in the range of 1 × 10 5 ~1×10 12 More preferably, it is in the range of 1×10 6 ~1×10 11 More preferably, it is in the range of cfu. In addition, in the present specification, when the Lactobacillus helveticus is a killed bacterium, cfu can be replaced with individual cells. The composition of the present invention can be taken once a day or in divided doses. It may be taken once every few days or weeks, but it is preferably taken every day. The period of intake is preferably 5 weeks or more.

[0066] The composition of the present invention may be ingested orally, but is not limited to this, and may be ingested, for example, nasally, through a gastrostomy or enterostomy, or may be ingested by a subject through a nasogastric feeding tube, for example.

[0067] The compositions of the present invention, which contain Lactobacillus helveticus and are intended to improve QOL, and in preferred embodiments, to improve insomnia, fatigue, or intestinal health, can all be used as pharmaceutical compositions or food and beverage compositions. For example, it is possible to provide a food and drink composition for improving QOL containing Lactobacillus helveticus, a food and drink composition for improving insomnia containing Lactobacillus helveticus, a food and drink composition for improving fatigue containing Lactobacillus helveticus, and a food and drink composition for intestinal regulation containing Lactobacillus helveticus. Hereinafter, these may be collectively referred to as the "food and drink composition of the present invention." In addition, it is possible to provide a pharmaceutical composition for improving QOL containing Lactobacillus helveticus, a pharmaceutical composition for improving insomnia containing Lactobacillus helveticus, a pharmaceutical composition for improving fatigue containing Lactobacillus helveticus, and a pharmaceutical composition for intestinal regulation containing Lactobacillus helveticus. Hereinafter, these may be collectively referred to as the "pharmaceutical composition of the present invention."

[0068] The food and drink composition of the present invention is not particularly limited as long as it contains the Lactobacillus helveticus. The food and drink composition may be in any form, such as liquid, paste, gel-like solid, powder, etc., and may be any food or drink, including tablet confectionery, liquid food, etc., as well as wheat flour products such as bread, macaroni, spaghetti, noodles, cake mix, fried chicken flour, breadcrumbs, etc.; instant noodles, cup noodles, retort / cooked foods, cooked canned foods, microwave foods, instant soups / stews, instant miso soup / cleansing soups, canned soups, freeze-dried foods, other instant foods, etc.; canned agricultural products, canned fruits, etc. processed agricultural products such as jams and marmalades, pickles, boiled beans, dried agricultural goods, cereals (processed grain products); processed marine products such as canned seafood, fish ham and sausages, seafood paste products, marine delicacies, and tsukudani; processed livestock products such as canned livestock pastes, livestock ham and sausages; dairy products such as processed milk, milk drinks, yogurt, lactic acid bacteria drinks, cheese, ice cream, modified milk powder, cream, and other dairy products; fats and oils such as butter, margarines, and vegetable oils; soy sauce, miso, sausage Basic seasonings such as seasonings, tomato processed seasonings, mirin, vinegar, etc.; complex seasonings and foods such as cooking mixes, curry bases, sauces, dressings, noodle soups, spices, and other complex seasonings; frozen foods such as ingredient frozen foods, semi-cooked frozen foods, and cooked frozen foods; confectioneries such as caramel, candy, gummy candy, chewing gum, chocolate, cookies, biscuits, cakes, pies, snacks, crackers, Japanese sweets, rice snacks, bean snacks, dessert snacks, jellies, and other sweets. Children: carbonated drinks, natural fruit juice, fruit juice drinks, soft drinks with fruit juice, fruit pulp drinks, fruit drinks with fruit particles, vegetable drinks, soy milk, soy milk drinks, coffee drinks, tea drinks, powdered drinks, concentrated drinks, sports drinks, nutritional drinks, alcoholic drinks, other beverages, and other commercially available foods such as baby food, furikake, and ochazuke nori; infant formula; enteral nutrition; special purpose foods, health functional foods (foods for specified health uses, foods with nutritional functions, foods with functional claims); nutritional supplements, etc. The food and drink composition of the present invention may be a supplement, for example, a tablet-shaped supplement, in which the Lactobacillus helveticus can be ingested without being affected by other foods in terms of daily meal amount and calorie intake.

[0069] The food and drink composition of the present invention can be produced by adding the Lactobacillus helveticus to the raw material of a normal food and drink, and can be produced in the same manner as normal food and drink, except for adding the Lactobacillus helveticus. The Lactobacillus helveticus may be added at any stage of the production process of the food and drink composition. In addition, the food and drink composition may be produced through a fermentation process using the added Lactobacillus helveticus. Examples of such food and drink compositions include lactic acid bacteria beverages and fermented milk. In addition, the composition may be added to breast milk or formula milk, and it is also assumed that the milk after addition is ingested by infants.

[0070] The food and drink composition of the present invention also includes raw materials for producing the food and drink composition, and food additives, etc., which are added to the food and drink composition during or after the production process of the food and drink composition. For example, the Lactobacillus helveticus can be used as a starter for producing fermented milk. The Lactobacillus helveticus can also be added to the produced fermented milk later.

[0071] In addition, the food and drink composition of the present invention can use known or future components having prebiotic effects or components that supplement the prebiotic effects (hereinafter referred to as "prebiotics"), as long as they do not impair the effects of the present invention. For example, the food and drink composition of the present invention can be produced by blending prebiotics such as whey protein, casein protein, soy protein, pea protein, or other proteins or mixtures or decomposition products thereof; amino acids such as leucine, valine, isoleucine, or glutamine; vitamins such as vitamin B6 or vitamin C; creatine; citric acid; fish oil; or oligosaccharides such as isomaltooligosaccharides, galactooligosaccharides, xylooligosaccharides, soybean oligosaccharides, fructooligosaccharides, and lactulose with the Lactobacillus helveticus.

[0072] The content of Lactobacillus helveticus in the food and beverage composition of the present invention is appropriately set depending on the form of the food and beverage composition, but the total amount is 1 × 10 4 ~1×10 13 cfu / g or 1×10 4 ~1×10 13 cfu / ml, preferably in the range of 1×10 5 ~1×10 12 cfu / g or 1×10 5 ~1×10 12 More preferably, the range is 1×10 6 ~1×10 11 cfu / g or 1×10 6 ~1×10 11 More preferably in the range of cfu / ml.

[0073] The intake amount of the food and drink composition of the present invention is appropriately determined depending on the form of the food and drink composition, the method of use, the subject, the age and sex of the subject, and other conditions, but is not particularly limited as long as it exerts a QOL improving effect, and in a preferred embodiment, an insomnia improving effect, a fatigue improving effect, or an intestinal regulation effect in the subject who ingests it.4 ~1×10 13 cfu, preferably in the range of 1 × 10 5 ~1×10 12 More preferably, it is in the range of 1×10 6 ~1×10 11 More preferably, it is in the range of cfu. The food and drink composition of the present invention can be ingested once or several times a day. It may also be ingested once every few days or weeks, but is preferably ingested daily. The ingestion period is preferably 5 weeks or more.

[0074] The food and drink composition of the present invention may be ingested alone, or may be ingested together with other food and drink compositions or foods and drinks, or pharmaceutical compositions or medicines. For example, it may be ingested together with other food and drink compositions or foods and drinks to improve QOL, or pharmaceutical compositions or medicines to improve QOL. This also applies when the improvement of the QOL is improvement of insomnia, improvement of fatigue, or regulation of intestinal function.

[0075] The food and drink composition of the present invention can be sold as a food and drink composition or food and drink labeled with the use for improving QOL, or in a preferred embodiment, for improving insomnia, improving fatigue, or for regulating intestinal function, etc. Needless to say, any other wording may be used as long as it expresses an effect secondary to the above-mentioned use.

[0076] The above-mentioned "indication" means any act for informing consumers of the above-mentioned uses, and any indication that can recall or infer the above-mentioned uses falls under the "indication" of the present invention, regardless of the purpose of the indication, the content of the indication, the object and medium on which it is displayed, etc. However, it is preferable to indicate the above-mentioned uses in an expression that allows consumers to directly recognize them. Specifically, examples include the act of describing the above-mentioned uses on the food and beverage composition or food and beverage product related to the present invention or on the product's packaging; the act of transferring, delivering, displaying for transfer or delivery, or importing a product or product packaging on which the above-mentioned uses are described; the act of describing the above-mentioned uses in advertisements, price lists, or transaction documents related to the product and displaying or distributing them; or the act of describing the above-mentioned uses in information containing these contents and providing them by electromagnetic means (such as the Internet), and the like. In particular, displaying on packaging, containers, promotional materials at the point of sale such as catalogs, pamphlets, POP, and other documents is preferred.

[0077] Moreover, the labeling is preferably a labeling approved by the government or the like (for example, a labeling approved based on various systems established by the government and made in a manner based on such approval). For example, labeling as a health functional food, more specifically, labeling as a health functional food, health food, functional food, enteral nutritional food, special purpose food, nutrient functional food, medical drug, etc. can be exemplified, and other labeling approved by the Consumer Affairs Agency, such as a labeling as a specified health food, a nutrient functional food, a functional food, and a labeling approved under a similar system, can be exemplified. Examples of the latter include labeling as a specified health food, a labeling as a conditional specified health food, a labeling that affects the structure or function of the body, a labeling for reducing the risk of disease, and a labeling of functionality based on scientific evidence. More specifically, labeling as a specified health food (particularly a labeling of health uses) as specified in the Cabinet Office Ordinance on the Permission of Special Purpose Labeling Provided in the Health Promotion Act (Cabinet Office Ordinance No. 57 of August 31, 2009), and similar labels can be exemplified.

[0078] When the food and beverage composition of the present invention is a food and beverage composition containing Lactobacillus helveticus for improving QOL, examples of the labeling include "For those who want to improve their QOL" and "For those who want to improve their quality of life."

[0079] In the case where the food and beverage composition of the present invention is a food and beverage composition for improving insomnia containing Lactobacillus helveticus, examples of the labeling include "for those who wish to improve insomnia", "for those who take a long time to fall asleep after going to bed", "for those who wake up in the middle of their sleep at night", "for those who wake up earlier than their desired wake-up time and are unable to fall asleep thereafter", "for those who do not have enough sleep, including nighttime sleep and daytime naps", "for those who are dissatisfied with the overall quality of their sleep", "for those who feel depressed during the day", "for those whose daytime physical and mental activity levels are reduced", "for those who feel sleepy during the day", "for those who feel sleepy or tired when waking up and cannot wake up refreshed", and "for those who are not in a good state of sleep".

[0080] In the case where the food and drink composition of the present invention is a food and drink composition for improving fatigue, which contains Lactobacillus helveticus, examples of the labeling include "for those who want to improve fatigue", "for those who are tired", "for those who feel lethargic", "for those who are exhausted", "for those who are worn out", "for those who are exhausted", "for those who are in a sluggish state", "for those who are fed up with things", "for those who are exhausted", "for those who feel fatigued", "for those who have problems with fatigue", "for those who need more rest", "for those who feel sleepy or sluggish", "for those who have difficulty starting something", "for those who start something without any problems but become weaker as they continue", "for those who lack motivation", "for those whose muscle strength is weaker than before", "for those who feel physically weak", "for those who have difficulty concentrating", "for those who have difficulty thinking clearly", "for those who make mistakes when speaking", "for those who have more difficulty than before in finding the right words", "for those with a worse memory than usual", "for those who have lost interest in things that they used to be interested in", "for those who feel fatigued", etc.

[0081] When the food and beverage composition of the present invention is a food and beverage composition for intestinal regulation containing Lactobacillus helveticus, examples of the labeling include "for those who wish to improve intestinal function", "for those who wish to regulate their stomach", "for those who wish to improve bowel movements", "for those who tend to be constipated", "for those with poor bowel movements", "for those who tend to have diarrhea", "for those with loose stomachs", etc.

[0082] Furthermore, an example of the food and drink composition of the present invention for human subjects is infant formula. Formulated milk includes powdered milk and liquid milk. In the Ministerial Ordinance on the Compositional Standards of Milk and Dairy Products (Milk Ordinance), modified milk powder is defined as "a powder made by processing raw milk, cow's milk, special cow's milk, or foods made using these as ingredients, or using them as the main ingredient, and adding nutrients necessary for infants." The ministerial ordinance defines modified liquid milk as "a liquid made by processing raw milk, cow's milk, special cow's milk, or foods made using these as ingredients, or using them as the main ingredient, and adding nutrients necessary for infants." In addition, the modified milk is a mixture of various nutritional components such as proteins, fats and oils, carbohydrates, minerals, and vitamins, and includes those processed into powder or liquid form. In addition, prepared milk further includes "powdered milk formula for infants," "liquid milk formula for infants," and "powdered milk formula for pregnant and lactating women," which are foods for special dietary uses defined in the Health Promotion Act, as well as forms such as powdered milk formula for young children, nutritional powder for adults, and nutritional powder for the elderly.

[0083] The pharmaceutical composition of the present invention is not particularly limited as long as it contains the Lactobacillus helveticus. As the pharmaceutical composition of the present invention, the Lactobacillus helveticus may be used as it is, or may be formulated by mixing with a physiologically acceptable liquid or solid pharmaceutical carrier.

[0084] The dosage form of the pharmaceutical composition of the present invention is not particularly limited, and specific examples thereof include tablets, pills, powders, liquids, suspensions, emulsions, granules, capsules, syrups, suppositories, injections, ointments, patches, eye drops, and nasal drops. In addition, when preparing the pharmaceutical composition, additives such as excipients, binders, disintegrants, lubricants, stabilizers, flavorings, diluents, surfactants, and injection solvents that are commonly used as pharmaceutical carriers can be used.

[0085] As the pharmaceutical carrier, various organic or inorganic carriers can be used depending on the dosage form. Examples of the carrier in the case of a solid preparation include an excipient, a binder, a disintegrant, a lubricant, a stabilizer, and a flavoring agent.

[0086] Examples of excipients include sugar derivatives such as lactose, sucrose, glucose, mannitol, and sorbitol; starch derivatives such as corn starch, potato starch, α-starch, dextrin, and carboxymethyl starch; cellulose derivatives such as crystalline cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose, and calcium carboxymethyl cellulose; gum arabic; dextran; pullulan; silicate derivatives such as light anhydrous silicic acid, synthetic aluminum silicate, and magnesium aluminometasilicate; phosphate derivatives such as calcium phosphate; carbonate derivatives such as calcium carbonate; and sulfate derivatives such as calcium sulfate.

[0087] Examples of binders include gelatin, polyvinylpyrrolidone, macrogol, and the like, in addition to the above-mentioned excipients.

[0088] Examples of disintegrants include the above-mentioned excipients, as well as chemically modified starch or cellulose derivatives such as croscarmellose sodium, sodium carboxymethyl starch, and crosslinked polyvinylpyrrolidone.

[0089] Examples of lubricants include talc; stearic acid; metal stearates such as calcium stearate and magnesium stearate; colloidal silica; waxes such as veegum and glomerulus; boric acid; glycol; carboxylic acids such as fumaric acid and adipic acid; sodium carboxylates such as sodium benzoate; sulfates such as sodium sulfate; leucine; lauryl sulfates such as sodium lauryl sulfate and magnesium lauryl sulfate; silicic acids such as silicic anhydride and silicic acid hydrate; starch derivatives, and the like.

[0090] Examples of the stabilizer include paraoxybenzoic acid esters such as methylparaben and propylparaben; alcohols such as chlorobutanol, benzyl alcohol, and phenylethyl alcohol; benzalkonium chloride; acetic anhydride; and sorbic acid.

[0091] Examples of flavoring agents include sweeteners, acidulants, and fragrances. In the case of a liquid preparation for oral administration, examples of the carrier used include a solvent such as water, a flavoring agent, and the like.

[0092] The content of the Lactobacillus helveticus in the pharmaceutical composition of the present invention is appropriately determined depending on the dosage form, method of use, subject, age, sex, type and severity of disease, and other conditions. 4 ~1×10 13 cfu / g or 1×10 4 ~1×10 13 cfu / ml, preferably in the range of 1×10 5 ~1×10 12 cfu / g or 1×10 5 ~1×10 12 More preferably, the range is 1×10 6 ~1×10 11 cfu / g or 1×10 6 ~1×10 11 More preferably in the range of cfu / ml.

[0093] The dosage of the pharmaceutical composition of the present invention to a subject is appropriately determined depending on the dosage form, method of use, subject, age, sex, type of disease, severity, and other conditions, but is not particularly limited as long as it exerts a QOL improving effect, and in a preferred embodiment, an insomnia improving effect, fatigue improving effect, or intestinal regulation effect, in the subject who takes it. 4 ~1×10 13 cfu, preferably in the range of 1 × 10 5 ~1×10 12 More preferably, it is in the range of 1×10 6 ~1×10 11 More preferably, it is in the range of cfu.

[0094] The administration time of the pharmaceutical composition of the present invention is not particularly limited, and the administration time can be selected appropriately. It may also be administered prophylactically. The administration form is preferably determined according to the formulation form, the subject, the subject's age, sex, the type of disease, the degree of the disease, and other conditions. In any case, the pharmaceutical composition of the present invention can be administered once a day or in multiple divided doses. It may also be administered once every few days or weeks, but it is preferable to administer it every day. The administration period is preferably 5 weeks or more.

[0095] The pharmaceutical composition of the present invention may be administered alone or together with other pharmaceutical compositions or medicines, or food and drink compositions or food and drink. For example, it may be administered together with other pharmaceutical compositions or medicines for improving QOL, or food and drink compositions or food and drink for improving QOL. This also applies when the improvement of the QOL is improvement of insomnia, improvement of fatigue, or regulation of intestinal function.

[0096] The present invention can provide the following aspects. <1> Use of Lactobacillus helveticus in the manufacture of a composition for improving quality of life. <2> Use of Lactobacillus helveticus to improve quality of life. <3> Lactobacillus helveticus, used to improve quality of life. <4> Lactobacillus helveticus for use in the prevention or treatment of diseases, symptoms, conditions or disorders that can be prevented or treated by improving quality of life. <5> A method for improving quality of life in a human, comprising administering to the human Lactobacillus helveticus or a composition for improving quality of life. <6> A method for preventing or treating a human disease, symptom, condition, disorder, etc. that can be prevented or treated by improving QOL, comprising the step of administering Lactobacillus helveticus or a composition for improving QOL to a human.

[0097] <7> Use of Lactobacillus helveticus in the manufacture of a composition for improving insomnia. <8> Use of Lactobacillus helveticus to improve insomnia. <9> Lactobacillus helveticus, used to treat insomnia. <10> Lactobacillus helveticus for use in the prevention or treatment of diseases, symptoms, conditions or disorders that can be prevented or treated by improving insomnia. <11> A method for improving insomnia in a human, comprising administering to the human Lactobacillus helveticus or a composition for improving insomnia. <12> A method for preventing or treating a human disease, symptom, condition, disorder, etc. that can be prevented or treated by improving insomnia, comprising the step of administering Lactobacillus helveticus or a composition for improving insomnia to a human.

[0098] <13> Use of Lactobacillus helveticus in the manufacture of a composition for improving fatigue. <14> Use of Lactobacillus helveticus to improve fatigue. <15> Lactobacillus helveticus, used to improve fatigue. <16> Lactobacillus helveticus for use in the prevention or treatment of diseases, symptoms, conditions or disorders which can be prevented or treated by improving fatigue. <17> 13. A method for improving fatigue in a human, comprising administering to the human Lactobacillus helveticus or a composition for improving fatigue. <18> A method for preventing or treating a human disease, symptom, condition or disorder that can be prevented or treated by improving fatigue, comprising the step of administering to a human Lactobacillus helveticus or a composition for improving fatigue.

[0099] <19> Use of Lactobacillus helveticus in the manufacture of a composition for intestinal regulation. <20> Use of Lactobacillus helveticus for intestinal regulation. <21> Lactobacillus helveticus, used for intestinal regulation. <22> Lactobacillus helveticus for use in the prevention or treatment of diseases, symptoms, conditions or disorders that can be prevented or treated by intestinal regulation. <23> A method for improving intestinal function in a human, comprising administering to the human Lactobacillus helveticus or a composition for intestinal regulation. <24> A method for preventing or treating a human disease, symptom, condition or disorder that can be prevented or treated by intestinal regulation, comprising the step of administering Lactobacillus helveticus or a composition for intestinal regulation to a human. EXAMPLES

[0100] The present invention will be specifically described below using examples, but the present invention is not limited to these examples.

[0101] <Subject> Subjects who met the following inclusion criteria and did not meet the exclusion criteria were included in the study. Thirteen subjects who met the criteria were enrolled. (Selection Criteria) 1) Women aged 20 to 65 2) Subjects with a POMS 2 short version FI (fatigue-lethargy) score of 50 or more at both screenings (exclusion criteria) 1) Those currently undergoing treatment for liver, kidney, heart, lung, digestive system, blood, endocrine system, or metabolic system, or those with a history of such serious illnesses 2) Subjects who regularly consume foods containing lactobacillus or bifidobacteria (such as supplements, excluding yogurt) 3) Subjects who regularly use medicines or supplements that affect mood or fatigue 4) Subjects with or a history of drug or severe food allergies 5) Pregnant women, women who intend to become pregnant during the study period, and women who are breastfeeding 6) Subjects who have participated in other drug or food trials within the past month 7) Subjects who are deemed inappropriate to be subjects by the study director or principal investigator based on the results of subject background, physical examination, medical examination, physical examination, etc. Before conducting this study, the purpose of the study was fully explained to all subjects, and written consent to participate was obtained from each subject. This study complied with the Declaration of Helsinki, was approved by the Ethics Committee of the Japan Clinical Research Council (a non-profit organization), and was conducted with the safety of the subjects as the first priority.

[0102] [Example 1] <Production of test samples> The bacterial culture of Lactobacillus helveticus MCC1848 (NITE BP-01671) was heat-sterilized, concentrated, and dried. The dried bacterial mass was mixed with maltodextrin and diluted to 2 × 10 10 The resulting bacterial powder was divided into stick film bags (1 g each) to prepare test samples.

[0103] <Test Method> A single-group before-and-after comparative study was conducted. Subjects were administered the test product once a day, one packet (2 × 10 10 The subjects were asked to take the 100mg of choline per cell (100mg of choline per cell) dissolved in water or other liquid and ingested it every morning before breakfast for five weeks.

[0104] <Statistical analysis> All 13 subjects were analyzed, and the values ​​of various tests before and after taking the test product were evaluated using a paired t-test. The results of the post-test questionnaire were evaluated using a univariate t-test with "no change" as the standard.

[0105] <Result> (Results of the short version of POMS2) The scores for the "Fatigue-Lethargy (FI)" item in the short version of POMS2 are shown in Table 1. The scores after taking the test product were significantly lower than the scores before taking the test product.

[0106] [Table 1]

[0107] (VAS results) The VAS scores for the items "feeling fatigued" and "feeling exhausted" are shown in Table 2. The scores after taking the test product were significantly lower than the scores before taking the test product.

[0108] [Table 2]

[0109] (CFS results) The results of the total scores of the items evaluated by CFS are shown in Table 3. The values ​​before and after taking the test product were compared as the base line, and there was a significant decrease.

[0110] [Table 3]

[0111] (Results of the Athens Insomnia Scale) The results of the total score of the items evaluated by the Athens Insomnia Scale are shown in Table 4. The values ​​before and after taking the test product were taken as the base line, and there was a significant decrease in the values ​​after taking the test product.

[0112] [Table 4]

[0113] (Survey results) The results of the questionnaire are shown in Table 5. In all categories of "stomach condition," "fatigue / body lethargy," and "quality of sleep / ease of awakening," the number of people who answered "better" or "slightly better" was significantly higher than the number of people who answered "no change," "slightly worse," or "worse" compared to before taking the test product.

[0114] [Table 5]

Claims

1. Contains Lactobacillus helveticus MCC1848 (NITE BP-01671) to improve insomnia Composition for.

2. The composition according to claim 1 , wherein the insomnia is represented by the total score of items assessed by the Athens Insomnia Scale.

3. The composition according to claim 1 or 2, wherein the insomnia is one or more insomnia selected from the group consisting of the following (1) to (8): (1) It takes a long time for you to actually fall asleep after getting into bed (2) Waking up during the night (3) Waking up earlier than your desired wake-up time and being unable to fall asleep after that (4) Not getting enough sleep, including nighttime sleep and daytime naps (5) Being dissatisfied with the overall quality of your sleep (6) Feeling depressed during the day (7) A state of reduced daytime physical and mental activity. (8) Feeling sleepy during the day

4. The composition of claim 1 , which improves sleep quality and / or wakefulness.

5. The composition according to any one of claims 1 to 4, which is a food or drink composition.

6. The composition according to any one of claims 1 to 4, which is a pharmaceutical composition.

Images