A study to evaluate the efficacy of lactic acid bacteria beverages.
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000052743
- Lead Sponsor
- HUMA R&D CORP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Not provided
1.Subjects who routinely use drugs and quasi-drugs that improve intestinal health (e.g., intestinal drugs, constipation remedies [including laxatives]). 2.Subjects who are receiving drugs that affect the intestinal microbiota such as antibiotics. 3.Subjects with serious medical conditions such as diabetes, renal/hepatic impairment and heart disease, thyroid or adrenal gland disease, or other metabolic problems and those who are receiving medical treatment. 4.Subjects who are unable to refrain from eating food products that are known to help relieve constipation (e.g., yogurt, oligosaccharides) during the study period. 5.Subjects who habitually drink more alcohol than the recommended upper limit (i.e., mean daily alcohol consumption of about 40 g of pure alcohol equivalent; for example, two middle-size bottles [1000 mL] of beer). 6.Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. 7.Subjects at risk for allergic reactions to the material of the test food (milk protein). 8.Subjects receiving exercise or diet therapy under the supervision of physicians. 9.Subjects with current or previous history of drug dependence or alcohol dependence. 10.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past. 11.Night or shift workers with extremely irregular life patterns. 12.Subjects whose eating, sleeping, and other habits are extremely irregular. 13.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period. 14.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent. 15.Subjects who have difficulty complying with recording of each survey form.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Defecation related survey integrated score (DRSIS)
- Secondary Outcome Measures
Name Time Method (Secondary outcomes) Stool tests (e.g., stool pH, concentrations of metabolites, gut microbiota) (Safety evaluation) Adverse events