An evaluation test for alteration of the intestinal environment by probiotics consumptio
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000028733
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 36
Not provided
(1) Subjects who didn't undergo abdominal surgical operation within 6 month before the test. (2) Subjects who didn't take antibiotics for 1 week or more within 6 month before the test. (3) Subjects who have allergy to test food. (4) Smokers (5) Subjects who are heavy drinkers of alcohol. (6) Subjects who are living together (consort or partner etc.) has planned to participate to the same clinical test. (7) Subjects who plan big change of lifestyle during the test. (8) Subjects with tendency of chronic diarrhea. (9) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. (10) Subjects who suspected chronic or serious infectious disease. (11) Females who are pregnant (including the possibility of pregnancy) or are lactating. (12) Subjects who have participated the other clinical test within 1 month before the test. (13) Subjects who have consumed medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) in the last 2 weeks before the day of preliminary examination. (14) Subjects who cannot refrain from consumption of medicines and foods which affect intestinal environment during the test. (15) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 16S rRNA gene-based metagenome analysis of gut microbiome and metabolome analysis of intestinal metabolites
- Secondary Outcome Measures
Name Time Method * Defecation frequency * Property of stool * Volume of stool