WO2021111981A1 - Agent pour la prévention ou le traitement de la démence et composition le contenant - Google Patents

Agent pour la prévention ou le traitement de la démence et composition le contenant Download PDF

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WO2021111981A1
WO2021111981A1 PCT/JP2020/044054 JP2020044054W WO2021111981A1 WO 2021111981 A1 WO2021111981 A1 WO 2021111981A1 JP 2020044054 W JP2020044054 W JP 2020044054W WO 2021111981 A1 WO2021111981 A1 WO 2021111981A1
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agent
dementia
lactic acid
preventing
acid bacterium
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PCT/JP2020/044054
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English (en)
Japanese (ja)
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勝太郎 永田
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株式会社ライフ・クオリティ研究所
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Priority to JP2021562610A priority Critical patent/JP7057039B2/ja
Publication of WO2021111981A1 publication Critical patent/WO2021111981A1/fr

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K10/00—Animal feeding-stuffs
    • A23K10/10—Animal feeding-stuffs obtained by microbiological or biochemical processes
    • A23K10/16—Addition of microorganisms or extracts thereof, e.g. single-cell proteins, to feeding-stuff compositions
    • A23K10/18—Addition of microorganisms or extracts thereof, e.g. single-cell proteins, to feeding-stuff compositions of live microorganisms
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/718—Starch or degraded starch, e.g. amylose, amylopectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/729—Agar; Agarose; Agaropectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/731—Carrageenans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/732—Pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/733—Fructosans, e.g. inulin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/734—Alginic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/736—Glucomannans or galactomannans, e.g. locust bean gum, guar gum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
    • 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
    • A61K36/02—Algae
    • 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)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/68—Plantaginaceae (Plantain Family)
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Definitions

  • the present invention relates to agents and compositions for preventing, treating or ameliorating dementia, and more specifically, agents for preventing, treating or ameliorating dementia containing lactic acid bacteria and / or lactic acid bacteria-derived ingredients as active ingredients. With respect to the composition containing it.
  • Dementia is a condition in which forgetfulness or cognitive decline occurs, which interferes with daily life. Forgetfulness and cognitive decline occur when nerve cells in the brain are damaged and die, and the number of normal nerve cells decreases. When dementia develops, behavioral and psychological changes occur.
  • Dementia can be broadly divided into two types according to the cause of the decrease in the number of normal brain nerve cells.
  • One is degenerative dementia, which is caused by changes in the degeneration and loss of nerve cells in the brain.
  • Dementia dementia includes Alzheimer's disease, Lewy body dementias, Parkinson's disease with dementia, frontotemporal dementia, and the like.
  • the other is secondary dementia, which develops due to some trauma or illness.
  • Secondary dementia includes cerebrovascular dementia, normal pressure hydrocephalus, chronic subdural hematoma, brain tumors, spontaneous hypoglycemia and the like.
  • Alzheimer-type dementia, Lewy body dementia, and cerebrovascular dementia are the three major dementias, and the total is thought to account for around 80% of all dementia.
  • NMDA N-methyl-D-aspartate
  • the above-mentioned drugs approved in Japan have sufficiently recovered from dementia and stopped the progression.
  • the above-mentioned drugs may cause side effects such as liver dysfunction, digestive disorders such as nausea and diarrhea, dizziness, and arrhythmia. Therefore, a more effective and less side-effecting agent for preventing, treating or ameliorating dementia is desired.
  • Lactis KLAB-4 strain KLAB-4 is a strain isolated from fermented milk, and is a novel lactic acid bacterium belonging to the genus Lactobacillus delbricky subspecies lactis. Deposited with the Independent Administrative Institution Product Evaluation Technology Infrastructure Organization (2-5-8 Kazusakamatari, Kisarazu City, Chiba Prefecture, Japan) (Deposit No. NITE BP-394; Original Deposit Date August 9, 2007 Domestic Deposited Strains Was transferred to an international deposit based on the Budapest Treaty (September 22, 2008). It is known that this lactic acid bacterium has an excellent anti-allergic function, and further has an anti-autoimmune disease function, a diabetes improving function and a hypoglycemia improving function (Patent Documents 1 and 3 and Non-Patent Document 2).
  • Patent Document 2 describes that Lactobacillus pentosus variant Plantalum C29 and Lactobacillus carbatus C3, which are lactic acid bacteria isolated from kimchi, have preventive and / or therapeutic activity for aging and dementia. There is.
  • An object of the present invention is to provide an agent for preventing or ameliorating dementia, which is highly safe and effective, has few side effects, and can be used continuously for a long period of time.
  • a preventive or ameliorating agent for dementia containing the lactic acid bacterium Lactobacillus delbricky subspecies lactis or a component derived from the lactic acid bacterium as an active ingredient; [2] The dementia according to the above [1], wherein the lactic acid bacterium contains a lactic acid bacterium selected from the group consisting of Lactobacillus delbricky Subspecies Lactis KLAB-4 strain (NITE BP-394) and a mutant thereof.
  • Preventive or ameliorating agent [3] The agent for preventing or ameliorating dementia according to the above [1] or [2], which further contains a water-soluble dietary fiber component or is used in combination with a water-soluble dietary fiber component; [4]
  • the water-soluble dietary fiber component is glucomannan, pectin, guar gum, alginic acid, polydextrose, ⁇ -glucan, fructan, inulin, levan, laminan, arabic gum, martitol, psyllium, indigestible oligosaccharide, and indigestible.
  • Dementia can be degenerative dementia, especially Alzheimer's disease.
  • the dementia preventive or ameliorating agent can be a dementia ameliorating agent.
  • the agent for preventing or improving dementia of the present invention and the composition containing the same can effectively improve dementia. Since the agent for improving dementia and the composition containing it of the present invention contains highly safe lactic acid bacteria or a component derived from the lactic acid bacteria as an active ingredient, there is no concern about side effects even if it is administered or ingested for a long period of time. Highly safe. In addition, a water-soluble dietary fiber component such as glucomannan is also a beneficial component having many years of eating experience for humans and is highly safe. Therefore, the dementia-improving agent of the present invention and the composition containing the same can be used prophylactically or therapeutically.
  • FIG. 1 is a graph showing changes in the average value of the number of applicable subjects among the “10 symptoms” of dementia counted immediately before the start of the test and immediately after the end of the test for each group of subjects. “**” indicates that the number immediately after the end of the test is significantly reduced with a risk rate of 1% (p ⁇ 0.01) compared to the number immediately before the start of the test.
  • FIG. 2 is a graph showing the rate of change (%) in the number of dementia symptoms in each group immediately before the start of the test and immediately after the end of the test (that is, before and after taking the capsule).
  • the preventive or ameliorating agent for dementia of the present invention contains the lactic acid bacterium Lactobacillus delbricky subspecies lactis or a component derived from the lactic acid bacterium as an active ingredient. Therefore, the agent of the present invention can consist only of the lactic acid bacterium Lactobacillus delbricky subspecies lactis or a component derived from the lactic acid bacterium, and can also contain other active ingredients.
  • Lactobacillus delbricky subspecies lactis used in the present invention can be isolated from fermented milk or fermented foods such as cheese, or the isolated strain can be obtained and used. it can.
  • the lactic acid bacteria used in the present invention include a group consisting of Lactobacillus delbrueckii subsp. Lactis KLAB-4 (hereinafter also referred to as "KLAB-4 strain") and variants thereof. It is desirable to include lactic acid bacteria selected from.
  • the KLAB-4 strain is a strain described in detail in Patent Document 1 (Patent No. 5554994). Since it was confirmed that the sequence from the 5'-terminal base of the 16s rRNA gene to the 544th base of this strain has 90% or more homology with the lactobacillus delbricky subspecies lactis standard strain, lacto It was identified as Lactis, a subspecies of the genus Delbricky.
  • the preferred lactic acid bacterium for use in the present invention is not only the KLAB-4 strain but also a mutant thereof.
  • Such mutants are not particularly limited, and are those obtained by spontaneous mutation, those obtained by artificially inducing mutation by a known method such as exposure to radiation or a mutation-inducing substance, and the like. Can be done.
  • the mutant can be used in the present invention as long as it has the same characteristics as KLAB-4 lactic acid bacteria (particularly, it has a preventive or ameliorating effect on dementia).
  • Lactobacillus lactobacillus delbricky subspecies lactis for example, KLAB-4 strain or a mutant thereof, can be cultured by a known general medium and method.
  • These lactic acid bacteria are cultured in a medium in which these bacteria can grow, for example, MRS medium, in a container such as a fermentation jar, a test tube, a bottle, or a flask, which is usually used under general culture conditions. Can be cultivated by performing.
  • the lactic acid bacterium used in the present invention may be a live bacterium or a dead bacterium.
  • Live bacteria refer to live cells
  • dead bacteria refer to cells that have been sterilized by heating, pressurizing, or treating with drugs.
  • the lactic acid bacterium-derived component obtained from the lactic acid bacterium can also be used in the present invention in the same manner as the bacterial cell as long as it has the same function.
  • the lactic acid bacterium-derived component refers to a part or component of a bacterial cell, or a component containing any of them.
  • lactic acid bacterium is ground, crushed, extracted, fractionated, dried, heated, frozen, cooled, concentrated, diluted, etc.
  • the lactic acid bacterium-derived component may be in any form such as liquid, paste, powder, and granules.
  • the residue after extracting some component from the cells may be used, and for example, the residue after hot water extraction may be used.
  • the KLAB-4 strain lactic acid bacterium powder is commercially available under the trade name "lactic acid bacterium LAB4" (manufactured by Kaneka Corporation), so that it may be used.
  • the agent for preventing or improving dementia of the present invention may contain a water-soluble dietary fiber component in addition to the above-mentioned lactic acid bacteria or components derived from lactic acid bacteria. It has been found that the effect of the agent of the present invention is enhanced by further containing such a component.
  • the water-soluble dietary fiber component refers to water-soluble dietary fiber or a food / pharmaceutical product or food / pharmaceutical material containing the same.
  • Specific examples of the water-soluble dietary fiber component include glucomannan, pectin, guar gum, alginic acid, polydextrose, ⁇ -glucan, fructan, inulin, levan, graminan, arabic gum, maltitol, psyllium, and indigestible oligosaccharides.
  • Examples include natural or synthetic water-soluble or synthetic fiber-containing materials such as refractory dextrin, agarose, sodium alginate, carrageenan, fucoidan, porphyran, laminaran, and seaweed and agar.
  • the water-soluble dietary fiber component may be contained in the agent of the present invention, or may be combined with lactic acid bacteria or a component derived from lactic acid bacteria at the time of administration or ingestion. Alternatively, they can be administered or ingested as separate preparations containing each, in which case both may be administered or ingested simultaneously or at back and forth in time.
  • the agent or composition of the present invention is not only when the lactic acid bacterium or the component derived from the lactic acid bacterium and the water-soluble dietary fiber component are contained in the same composition, but also as separate agents or compositions at the same time or before and after. May be administered or ingested.
  • the agent of the present invention in the form of being encapsulated can be taken in a beverage containing a water-soluble dietary fiber component.
  • the ratio is not particularly limited, but for example, lactic acid bacteria or a component derived from lactic acid bacteria.
  • About 0.1 to 2 parts of the water-soluble dietary fiber component is preferable with respect to 1 part.
  • glucomannan is highly hydrophilic and can absorb about 100 times the weight of glucomannan, so that the volume of glucomannan increases about 100 times by absorbing water in the stomach. Then, it is considered that a thin film is stretched on the gastric mucosa. Therefore, one possibility is that the presence of a water-soluble dietary fiber component can regulate the absorption of lactic acid bacteria.
  • the dementia preventive or ameliorating agent of the present invention contains lactic acid bacteria or lactic acid bacteria-derived components as described above as the only essential component, but may contain or use other active ingredients such as water-soluble dietary fiber components. it can.
  • the composition containing the agent for preventing or ameliorating dementia of the present invention contains one or more other ingredients in addition to the agent of the present invention.
  • the composition of the present invention may be a pharmaceutical composition, a food or drink composition, an animal feed composition, an animal pharmaceutical composition, or the like, and the specific form thereof is not particularly limited.
  • the composition of the present invention when used as a pharmaceutical product, it may be in the form or dosage form of capsules, tablets, pills, powders, granules, drinks, syrups, injections, infusions, nasal drops, eye drops. Examples include agents, suppositories, patches, sprays and the like.
  • the composition of the present invention when used as a food or drink composition, it may be in the form of a general food together with various food raw materials or ingredients, or it may be a functional food such as a supplement in the form of a capsule or a tablet. You can also.
  • any component contained in the composition of the present invention can be appropriately selected according to the properties, form, production method, etc. of the composition, and various components and additives known in the industry such as pharmaceuticals, foods, and cosmetics. Can be.
  • Additives that may be included in the compositions of the present invention include excipients, disintegrants, and lubricants that are pharmaceutically acceptable or routinely used in industries such as pharmaceuticals, foods and cosmetics. Examples include swamps, binders, surfactants, fluidity promoters, colorants, solvents, thickeners, dispersants, pH regulators, moisturizers, stabilizers, preservatives, fragrances and the like.
  • the excipients used are lactose, sucrose, glucose.
  • binders disintegrants, surfactants, lubricants, fluidity promoters, antioxidants, anti-aggregation agents, absorption promoters, dissolution aids, stabilizers, preservatives, moisture proofing agents. , Colorants, fragrances and the like can be used as appropriate.
  • binder examples include starch, dextrin, arabic gum powder, gelatin, hydroxypropyl starch, carboxymethyl cellulose / sodium salt, methyl cellulose, crystalline cellulose, ethyl cellulose, and polyvinylpyrrolidone.
  • Disintegrants include starches, carboxymethyl cellulose (CMC), hydroxypropyl cellulose (HPC), carboxymethyl cellulose sodium salt, polyvinylpyrrolidone and the like.
  • Surfactants include soybean lecithin and sucrose fatty acid esters, talc, wax, sucrose fatty acid esters, hydrogenated vegetable oils, calcium stearate, magnesium stearate and the like as lubricants, and anhydrous as fluidity promoters. Examples thereof include silicic acid, dry aluminum hydroxide, and magnesium silicate.
  • composition of the present invention is used as an animal feed or an animal pharmaceutical composition
  • various feed raw materials or pharmaceutically acceptable ingredients are used to prepare feeds, supplements, pharmaceuticals and the like. It can be in the desired form or dosage form.
  • agent or composition of the present invention may be administered or used alone or in combination with other agents.
  • agent or composition of the present invention when used in combination with another agent, both may be used at the same time, or both may be used before and after.
  • the administration (or ingestion or application) route of the dementia preventive or ameliorating agent or composition of the present invention can be appropriately selected from, for example, oral, transdermal, enteral, rectal routes and the like.
  • the daily dose (or ingestion or application) of the agent or composition of the present invention effective for the prevention or amelioration of dementia is the formulation form, method and route of administration, age and body weight of the subject, and disease. Although it depends on the severity and the like, for example, in the case of the oral route, in humans, the amount of the active ingredient lactic acid bacteria or lactic acid bacteria-derived component is generally about 0.1 mg to about 1000 mg / kg body weight / day, preferably about 1 mg to about.
  • 500 mg / kg body weight / day can be administered or ingested at one time or in divided portions.
  • the timing of administration or ingestion is not particularly limited, and may be, for example, at the same time as a meal, immediately after a meal, immediately before a meal, before sleep, or the like.
  • the agent or composition of the present invention is extremely safe, it can be given not only to patients but also to healthy subjects.
  • the agent or composition of the present invention can be similarly administered (or ingested or applied) to a subject, specifically a human and a non-human animal, preferably a mammal.
  • non-human animals include domestic animals such as cows, horses, pigs and sheep, and companion animals such as dogs and cats.
  • the dose can be adjusted according to the characteristics of the animal based on the same amount as described above.
  • the amount of lactic acid bacteria or components derived from lactic acid bacteria is about 0.01 to about 1000 mg / kg body weight / day, more preferably about 0.1 to about 30 mg / kg body weight / day. It can be adjusted and given.
  • Whether or not the agent or composition of the present invention has improved dementia is determined at different time points, such as before and after administration or ingestion, or during or after administration or ingestion, at a later time point as compared with the previous time point. It can be evaluated by examining whether or not the symptoms have changed in. For example, it can be evaluated by diagnosing the degree of dementia by the presence or absence of "10 symptoms" indicated by the American Alzheimer's Association before the start of administration and after administration for a certain period (for example, 6 months).
  • Production Example 1 Per capsule, 100 mg of lactic acid bacteria powder, 50 mg of glucomannan powder, 17.5 mg of crystalline cellulose powder, 2 mg of calcium stearate powder, and 0.5 mg of silicon dioxide powder are mixed and stirred to make them uniform, and then a commercially available capsule (trade name "Pig"). It was filled in "Gelatin Clear No. 3" (manufactured by Qualicaps Co., Ltd.).
  • Production example 2 One capsule contains 100 mg of lactic acid bacteria powder, 50 mg of lactose, 17.5 mg of crystalline cellulose powder, 2 mg of calcium stearate powder, and 0.5 mg of silicon dioxide powder. Was filled into capsules. Comparative example: Instead of the lactic acid bacteria powder and the glucomannan powder, the same capsules as in Production Example 1 were produced except that they contained 150 mg of lactose.
  • ⁇ Subject> The subjects were 33 untreated patients (17 males and 16 females) who were diagnosed with dementia by a specialist. These were divided into three groups by the envelope method: a placebo (P) group, a lactic acid bacterium group (L) group, and a lactic acid bacterium + glucomannan (M) group.
  • P placebo
  • L lactic acid bacterium
  • M lactic acid bacterium + glucomannan
  • Table 2 shows the breakdown of the subjects that make up each group.
  • ⁇ Test method> A double-blind method was adopted. Group P, L, or M were allowed to take the capsules of Comparative Example, Production Example 2, or Production Example 1 as described above in an amount of 3 capsules (1 capsule at a time) immediately after meals, respectively. It was. The administration period was 6 months.
  • ⁇ Test results> Changes in the number of dementia symptoms in each group of subjects For each group of subjects, the number of applicable dementia symptoms counted immediately before the start of the test and immediately after the end of the test. The change in the average value is shown in FIG. The statistical figures were expressed by the average value ⁇ standard deviation and analyzed by the MAC version of the statistical software SSMC.
  • Rate of change in the number of dementia symptoms before and after taking capsules (%) The rate of change (%) in the number of dementia symptoms was calculated by the formula: [(number of symptoms after administration-number of symptoms before administration) / number of symptoms before administration] ⁇ 100. The results are shown in FIG.
  • the agent and composition of the present invention are effective in improving dementia.
  • the agents and compositions of the present invention are all safe, and their contents are considered to be safe materials.

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Abstract

La présente invention concerne un agent pour la prévention ou le traitement de la démence, l'agent ayant une sécurité et une efficacité élevées, ayant moins d'effets secondaires et pouvant être utilisé pendant une longue période. Un aspect de la présente invention est un agent pour la prévention ou le traitement de la démence, l'agent contenant Lactobacillus delbrueckii subsp. Lactis ou un composant dérivé de la bactérie lactique comme principe actif.
PCT/JP2020/044054 2019-12-02 2020-11-26 Agent pour la prévention ou le traitement de la démence et composition le contenant WO2021111981A1 (fr)

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WO2024096644A1 (fr) * 2022-11-02 2024-05-10 주식회사 종근당바이오 Nouvelle utilisation de la souche lactobacillus delbrueckii sous-espèce lactis

Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2009066681A1 (fr) * 2007-11-19 2009-05-28 Kaneka Corporation Préparation contenant une bactérie d'acide lactique

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JP6879297B2 (ja) * 2016-04-13 2021-06-02 味の素株式会社 加齢に伴う身体機能低下もしくは身体機能障害、または加齢に伴う精神機能低下もしくは精神機能障害の抑制または改善用組成物

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009066681A1 (fr) * 2007-11-19 2009-05-28 Kaneka Corporation Préparation contenant une bactérie d'acide lactique

Non-Patent Citations (2)

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BULACIOS, G.A. ET AL.: "Selection of lactic acid bacterial strains able to modulate the host central nervous system", BIOCELL, vol. 43, no. 5, 7 November 2019 (2019-11-07), pages 116 *
NAKAMURA, SADAKO ET AL.: "Daily Feeding of Fructooligosaccharide or Glucomannan Delays Onset of Senescence in SAMP8 Mice", GASTROENTEROL. RES. PRACT., vol. 2014, no. 303184, 2 June 2014 (2014-06-02), pages 1 - 11, XP055832248 *

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