FR3004110A1 - COMPOSITION FOR COMBATING STRESS - Google Patents
COMPOSITION FOR COMBATING STRESS Download PDFInfo
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- FR3004110A1 FR3004110A1 FR1352992A FR1352992A FR3004110A1 FR 3004110 A1 FR3004110 A1 FR 3004110A1 FR 1352992 A FR1352992 A FR 1352992A FR 1352992 A FR1352992 A FR 1352992A FR 3004110 A1 FR3004110 A1 FR 3004110A1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/745—Bifidobacteria
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/22—Anxiolytics
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- Life Sciences & Earth Sciences (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
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- Natural Medicines & Medicinal Plants (AREA)
- Neurology (AREA)
- Biotechnology (AREA)
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- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Alternative & Traditional Medicine (AREA)
- Biomedical Technology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Nutrition Science (AREA)
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- Polymers & Plastics (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Abstract
L'objet de l'invention est un principe actif nutritionnel ou pharmaceutique destiné à une administration par voie orale, comprenant l'association : - d'un extrait de Crocus sativus, et - d'au moins une souche bactérienne probiotique. L'invention vise également une composition nutritionnelle comprenant un tel principe actif.The object of the invention is a nutritional or pharmaceutical active ingredient intended for oral administration, comprising the combination of: - an extract of Crocus sativus, and - at least one probiotic bacterial strain. The invention also relates to a nutritional composition comprising such an active ingredient.
Description
COMPOSITION POUR LUTTER CONTRE LE STRESS La présente invention concerne une composition nutritionnelle destinée à une administration par voie orale et à son utilisation pour aider à lutter contre le stress et les pathologies associées. Les situations de stress et d'anxiété sont des situations courantes dans nos 5 sociétés du fait du mode de vie actuel. Le stress, l'anxiété, l'hostilité sociale, les troubles obsessionnels compulsifs, les comportements dépressifs, sont généralement traités par des antidépresseurs. Si les molécules utilisées sont souvent efficaces, elles présentent de nombreux effets secondaires comme par exemple des troubles du sommeil, des troubles du 10 comportement, des problèmes gastro-intestinaux, etc. En outre, les antidépresseurs sont connus pour entraîner une forte addiction à leur consommation, et ne sont pas adaptés aux cas les moins graves qui sont pourtant les plus courants. C'est pourquoi, l'objectif de la présente invention est de proposer un principe 15 actif nutritionnel ou pharmaceutique avec des ingrédients d'origine naturelle palliant ces inconvénients. Pour y répondre, l'invention vise un principe actif destiné à une administration par voie orale, comprenant l'association - d'un extrait de Crocus sativus, et 20 - d'au moins une souche bactérienne probiotique. On connaît des principes actifs à base de Crocus sativus d'une part et des principes actifs à base de souches bactériennes probiotiques d'autre part, mais ces principes actifs ne sont pas efficaces pour permettre une gestion globale du stress. Selon l'invention l'association d'un extrait de Crocus sativus et d'au moins une souche bactérienne probiotique présente un effet synergique et une action 5 simultanée sur le système digestif et le système nerveux central pour une gestion globale du stress et de l'équilibre émotionnel. Avantageusement, le principe actif selon l'invention peut être utilisé pour prévenir ou lutter contre l'anxiété, la colère, l'hostilité sociale, les troubles obsessionnels compulsifs, les idées paranoïaques et/ou la dépression légère chez 10 l'homme. L'invention vise également les compositions nutritionnelles destinées à être intégrées dans un aliment ou un complément alimentaire, comprenant un tel principe actif, ainsi que les aliments et compléments alimentaires comprenant lesdites compositions nutritionnelles ou le principe actif. 15 L'invention est à présent décrite en détails. L'invention vise donc un principe actif nutritionnel ou pharmaceutique, destiné à une administration par voie orale, comprenant l'association - d'un extrait de Crocus sativus, et - d'au moins une souche bactérienne probiotique. 20 Par extrait de Crocus sativus on entend toute partie de la plante ou toute molécule ou mélange de molécules extraites de tout ou partie de la plante. Préférentiellement l'extrait de Crocus sativus est du safran ou un extrait de safran. Encore plus préférentiellement, l'extrait de Crocus sativus est issu de stigmates de Crocus sativus entiers ou réduits en poudre. Les stigmates sont 25 préférentiellement des stigmates séchés. Selon un mode de réalisation adapté, l'extrait de Crocus sativus, mesuré par analyse spectrophotométrique UV, a un coefficient d'extinction minimum de 9,5 pour la longueur d'onde de 330nm. Un tel extrait est particulièrement efficace dans le cadre de l'invention. La ou les souche(s) bactérienne(s) présente(s) dans le principe actif sont choisies parmi les bactéries probiotiques. Préférentiellement la ou les souche(s) bactérienne(s) probiotiques(s) sont choisies parmi les genres Lactobacillus, Lactococcus, Bifidobacterium et Enterococcus, encore plus préférentiellement parmi les Lactobacilluset Bifidobacterium. Selon un mode de réalisation particulièrement adapté, le principe actif selon l'invention comprend au moins deux souches bactériennes probiotiques, 10 préférentiellement au moins une souche bactérienne du genre Lactobacillus et au moins une souche bactérienne du genre Bifidobacterium. Le principe actif peut être intégré dans une composition nutritionnelle ou pharmaceutique pour une utilisation spécifique. En particulier, il peut être utilisé pour prévenir et/ou lutter contre le stress 15 chez l'humain. L'association Croccus sativus / souche(s) bactérienne(s) probiotique(s) permet de favoriser la gestion du stress et de l'équilibre émotionnel. Leur action en synergie permet de lutter efficacement contre le stress physiologique et le stress métabolique pour une gestion globale du stress. Il permet ainsi que limiter l'apparition de troubles du comportement tels que 20 l'anxiété, la colère, l'hostilité sociale, les troubles obsessionnels convulsifs, les idées paranoïaques ou la dépression légère. Il peut notamment être destiné à une administration - aux adultes exposés à une situation de stress prolongé, - aux femmes sujettes au syndrome prémenstruel, 25 - aux étudiants en déficit de concentration, - aux personnes âgées en dépression légère, - aux adultes en période de sevrage tabagique et/ou aux sportifs en situation d'entraînement intensif.The present invention relates to a nutritional composition for oral administration and its use to help fight against stress and associated pathologies. Stress and anxiety are common situations in our 5 societies due to the current way of life. Stress, anxiety, social hostility, obsessive compulsive disorder, depressive behavior, are usually treated with antidepressants. Although the molecules used are often effective, they have numerous side effects, such as, for example, sleep disorders, behavioral disorders, gastrointestinal problems, and the like. In addition, antidepressants are known to cause a strong addiction to their consumption, and are not adapted to the less serious cases that are most common. Therefore, the object of the present invention is to provide a nutritional or pharmaceutical active ingredient with ingredients of natural origin overcoming these disadvantages. In order to meet them, the invention is directed to an active ingredient intended for oral administration, comprising the combination of an extract of Crocus sativus, and at least one probiotic bacterial strain. Crocus sativus active ingredients are known on the one hand and active principles based on probiotic bacterial strains on the other hand, but these active principles are not effective to allow global management of stress. According to the invention, the combination of an extract of Crocus sativus and at least one probiotic bacterial strain has a synergistic effect and a simultaneous action on the digestive system and the central nervous system for a global management of stress and inflammation. emotional balance. Advantageously, the active ingredient according to the invention can be used to prevent or combat anxiety, anger, social hostility, obsessive-compulsive disorders, paranoid ideas and / or mild depression in man. The invention also relates to nutritional compositions intended to be incorporated into a food or a food supplement, comprising such an active principle, as well as foods and food supplements comprising said nutritional compositions or the active ingredient. The invention is now described in detail. The invention therefore relates to a nutritional or pharmaceutical active ingredient intended for oral administration, comprising the combination of - an extract of Crocus sativus, and - at least one probiotic bacterial strain. By Crocus sativus extract is meant any part of the plant or any molecule or mixture of molecules extracted from all or part of the plant. Preferably the Crocus sativus extract is saffron or a saffron extract. Even more preferentially, the extract of Crocus sativus is derived from stigmas of Crocus sativus whole or reduced to powder. The stigmas are preferentially dried stigmas. According to a suitable embodiment, the extract of Crocus sativus, measured by UV spectrophotometric analysis, has a minimum extinction coefficient of 9.5 for the wavelength of 330 nm. Such an extract is particularly effective in the context of the invention. The bacterial strain (s) present in the active principle are chosen from probiotic bacteria. Preferentially, the bacterial strain (s) probiotic (s) are selected from the genera Lactobacillus, Lactococcus, Bifidobacterium and Enterococcus, even more preferably from Lactobacillus and Bifidobacterium. According to a particularly suitable embodiment, the active principle according to the invention comprises at least two probiotic bacterial strains, preferably at least one bacterial strain of the genus Lactobacillus and at least one bacterial strain of the genus Bifidobacterium. The active ingredient can be integrated into a nutritional or pharmaceutical composition for a specific use. In particular, it can be used to prevent and / or fight against stress in humans. The combination Croccus sativus / strain (s) bacterial (s) probiotic (s) can promote the management of stress and emotional balance. Their synergistic action makes it possible to fight effectively against physiological stress and metabolic stress for a global management of stress. It thus helps to limit the occurrence of behavioral disorders such as anxiety, anger, social hostility, obsessive compulsive disorder, paranoid ideas or mild depression. In particular, it can be used for administration - to adults exposed to prolonged stress, - to women premenstrual syndrome, 25 - to students with impaired concentration, - to elderly people with mild depression, - to adults in a period of prolonged stress. Smoking cessation and / or athletes in intensive training.
Avantageusement, en plus de son efficacité, le principe actif selon l'invention ne provoque pas d'effet secondaire ou d'addiction et est parfaitement adapté à la prévention et la lutte contre le stress et les conséquences qui en découlent. Pour une efficacité optimale, le principe actif selon l'invention est préférentiellement constitué et administré en quantité adaptée pour permettre une administration journalière de 5 à 500mg d'extrait de Croccus sativus et de 500 millions à 25 milliards de bactéries vivantes. Selon un mode de réalisation, le principe actif selon l'invention est utilisé dans une composition nutritionnelle ou alimentaire. Par composition nutritionnelle ou 10 alimentaire on entend - les produits alimentaires, y compris les produits nutritionnels et les produits diététiques, - les compléments alimentaires avec une galénique répondant aux caractéristiques réglementaires, 15 - les compositions destinées à être intégrées dans des produits alimentaires, y compris dans les produits nutritionnels et les produits diététiques, - les compositions destinées à être intégrées dans des compléments alimentaires. 20 La composition nutritionnelle selon l'invention peut donc être utilisée en tant que telle comme produit alimentaire ou complément alimentaire ou intégrée dans un produit alimentaire ou un complément alimentaire. Préférentiellement, le complément alimentaire se présente sous forme de gélule, de poudre, de comprimé, de solution ou de gomme à mâcher. 25 De même, le produit alimentaire est préférentiellement choisi parmi les produits laitiers, les céréales, les barres céréalières et les boissons. De façon préférée, dans la composition nutritionnelle, la quantité d'extrait de Croccus sativus est comprise entre 0,1% et 20% en poids de matière sèche de la composition, en particulier entre 3 et 10% et plus préférentiellement entre 5 et 7%. be même, la quantité de souche(s) bactérienne(s) probiotique(s) est préférentiellement comprise entre 0,2% et 30% en poids de matière sèche de la composition, en particulier entre 2 et 15% et plus préférentiellement entre 4 et 7,5%. La viabilité correspondante des probiotiques est comprise entre 3.108 CFU/g et 4,2.1010 CFU/g, en particulier entre 3.109 CFU/g et 2.1010 CFU/g, et plus préférentiellement entre 5,6.109 CFU/g et 10,5.1010 CFU/g. La composition nutritionnelle ou alimentaire contient également un support alimentaire qui peut être choisi parmi les éléments suivants : une gomme arabique, une maltodextrine, une silice, de l'amidon, du lactose, une cellulose microcristalline, du glucose et du sel. La quantité de support alimentaire dans la composition est ajustée en fonction de la quantité des constituants du principe actif.Advantageously, in addition to its effectiveness, the active principle according to the invention does not cause a side effect or addiction and is perfectly suited to the prevention and the fight against stress and the consequences that result. For optimum effectiveness, the active ingredient according to the invention is preferably constituted and administered in an amount adapted to allow daily administration of 5 to 500mg of Croccus sativus extract and 500 million to 25 billion living bacteria. According to one embodiment, the active ingredient according to the invention is used in a nutritional or food composition. Nutritional or food composition is understood to mean food products, including nutritional products and dietary products, food supplements with a galenic product meeting the prescribed characteristics, compositions intended to be incorporated into food products, including in nutritional products and dietary products, - compositions intended to be incorporated in food supplements. The nutritional composition according to the invention can therefore be used as such as a food product or food supplement or integrated into a food product or a food supplement. Preferably, the food supplement is in capsule, powder, tablet, solution or chewing gum form. Similarly, the food product is preferably selected from dairy products, cereals, cereal bars and beverages. Preferably, in the nutritional composition, the amount of Croccus sativus extract is between 0.1% and 20% by weight of dry matter of the composition, in particular between 3 and 10% and more preferably between 5 and 7. %. the same, the amount of probiotic bacterial strain (s) is preferably between 0.2% and 30% by weight of dry matter of the composition, in particular between 2 and 15% and more preferably between 4 and and 7.5%. The corresponding viability of the probiotics is between 3.108 CFU / g and 4.2.1010 CFU / g, in particular between 3.109 CFU / g and 2.1010 CFU / g, and more preferably between 5.6.109 CFU / g and 10.5.1010 CFU / g. . The nutritional or food composition also contains a food carrier which can be selected from the following elements: gum arabic, maltodextrin, silica, starch, lactose, microcrystalline cellulose, glucose and salt. The amount of food carrier in the composition is adjusted according to the amount of the constituents of the active ingredient.
L'invention est à présent illustrée par des exemples non limitatifs de principe actif et de composition selon l'invention. I. extrait de Croccus sativus Un exemple d'extrait de Croccus sativus particulièrement adapté selon l'invention est un extrait obtenu par un procédé mettant en oeuvre les étapes sui vantes : - percolation de stigmates de Croccus sativus à l'éthanol (80%), - concentration à 35°C, - séchage par pulvérisation du liquide sur support maltodextrine. L'extrait présente les caractéristiques suivantes : - teneur en Safranal à la longueur d'onde de 330 nm : supérieure à 9, - teneur en Crocine à la longueur d'onde de 440 nm : supérieure à 24.The invention is now illustrated by non-limiting examples of active principle and composition according to the invention. I. Croccus sativus extract An example of a Croccus sativus extract particularly adapted according to the invention is an extract obtained by a process implementing the following steps: percolation of Croccus sativus stigmas with ethanol (80%) concentration at 35 ° C., spray drying of the liquid on a maltodextrin support. The extract has the following characteristics: - Safranal content at the wavelength of 330 nm: greater than 9, - Crocin content at the wavelength of 440 nm: greater than 24.
II. Probiotiques Des exemples de probiotiques particulièrement adaptés selon l'invention sont : Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus rhamnosus, Bifidobacterium longuet, Bifidobacterium lactis, Bifidobacterium casei, Bifidobacterium bifidum, Lactococcus lactis. III. Principe actif Un exemple de principe actif adapté selon l'invention est constitué des éléments suivants : 15% d'extrait de Croccus sativusdu point I, 15% d'un probiotique du genre Lactobacillus du point II, 3% d'un probiotique du genre Bifidobacterium du point II, 67% d'un support à base d'hydrate de carbone. Ce principe actif peut être obtenu comme suit : pesée des différents composants isolément, incorporer dans l'ordre pondéral décroissant, mélanger en condition anhydre sur support surséché, conditionnement. Les conditions de mise en oeuvre du procédé sont les suivantes : température comprise entre 5 et 30°C, préférentiellement entre 10 et 25°C et encore plus préférentiellement entre 18°C et 22°C, surpression, humidité relative comprise entre 15 et 60%, préférentiellement entre 20 et 40%, encore plus préférentiellement entre 25 et 35%.II. Probiotics Examples of probiotics particularly adapted according to the invention are: Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus rhamnosus, Bifidobacterium long, Bifidobacterium lactis, Bifidobacterium casei, Bifidobacterium bifidum, Lactococcus lactis. III. Active principle An example of an active ingredient adapted according to the invention consists of the following elements: 15% of Croccus sativus extract of point I, 15% of a probiotic of the genus Lactobacillus of point II, 3% of a probiotic of the genus Bifidobacterium of point II, 67% of carbohydrate carrier. This active principle can be obtained as follows: weighing of the various components in isolation, incorporate in descending order of weight, mix under anhydrous conditions on over-dried support, conditioning. The conditions for carrying out the process are as follows: temperature between 5 and 30 ° C., preferably between 10 and 25 ° C. and even more preferably between 18 ° C. and 22 ° C., overpressure, relative humidity between 15 and 60 ° C. %, preferably between 20 and 40%, even more preferably between 25 and 35%.
IV. Composition nutritionnelle incluant le principe actif : exemple de complément alimentaire Un exemple de composition selon l'invention est une composition se présentant sous forme de gélule, pour une utilisation comme complément alimentaire.IV. Nutritional Composition Including the Active Ingredient: Example of a Dietary Supplement An example of a composition according to the invention is a composition in capsule form, for use as a dietary supplement.
La composition comprend : - 8% de maltodextrines, - 8% de fructo-oligosaccharides, - 62% de principe actif du point III, - 20% de gélule d'hydroxy propyl méthyl cellulose, - 2% de stéarate de magnésium. La composition peut être obtenue comme suit : - pesées des composants isolément, - incorporation dans l'ordre pondéral décroissant, - mélange en condition anhydre, - conditionnement en gélule. Les conditions de mise en oeuvre du procédé sont les suivantes : température comprise entre 5 et 30°C, préférentiellement entre 10 et 25°C et encore plus préférentiellement entre 18°C et 22°C, surpression, humidité relative comprise entre 15 et 60%, préférentiellement entre 20 et 40%, encore plus préférentiellement entre 25 et 35%. Le conditionnement en gélule est réalisée dans des conditions et avec des équipements classiques et connus de l'homme de l'art. Les gélules peuvent être ensuite conditionnées en piluliers et sont utilisées 25 directement comme compléments alimentaires pour prévenir et/ou lutter contre le stress chez l'homme.The composition comprises: 8% of maltodextrins, 8% of fructo-oligosaccharides, 62% of active ingredient of point III, 20% of hydroxypropyl methyl cellulose capsule, 2% of magnesium stearate. The composition can be obtained as follows: - weighing of the components in isolation, - incorporation in descending order of weight, - mixing under anhydrous conditions, - packaging in capsule. The conditions for carrying out the process are as follows: temperature between 5 and 30 ° C., preferably between 10 and 25 ° C. and even more preferably between 18 ° C. and 22 ° C., overpressure, relative humidity between 15 and 60 ° C. %, preferably between 20 and 40%, even more preferably between 25 and 35%. The capsule packaging is performed under conditions and with conventional equipment and known to those skilled in the art. The capsules can then be packaged in pill boxes and are used directly as food supplements to prevent and / or fight against stress in humans.
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GR1010023B (en) * | 2020-03-27 | 2021-06-01 | ΙΟΥΛΙΑ ΚΑΙ ΕΙΡΗΝΗ ΤΣΕΤΗ ΦΑΡΜΑΚΕΥΤΙΚΑ ΕΡΓΑΣΤΗΡΙΑ Α.Β.Ε.Ε., με δ.τ. INTERMED ABEE | Stable orally administrated composition containing probiotics, crocus sativus and magnesium to treat mild anxiety and depression |
WO2021234111A1 (en) * | 2020-05-20 | 2021-11-25 | Activ' Inside | Composition comprising safranal and probiotics |
FR3110404A1 (en) * | 2020-05-20 | 2021-11-26 | Activ'inside | Composition comprising safranal and probiotics |
BE1028144B1 (en) * | 2020-08-20 | 2021-10-05 | Superbiotics | Probiotic composition comprising Lactobacillus, Bifidobacterium and a saffron extract for the treatment or prevention of disorders of the large intestine |
EP4104847A1 (en) * | 2021-06-16 | 2022-12-21 | Galenus G.H. AG | Composition for the treatment of mood disorders |
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