The effects of a probiotic on gut environment in both young and elderly in an urban community in Kolkata, INDIA
Phase 3
Completed
- Registration Number
- CTRI/2012/03/002491
- Lead Sponsor
- Okayama University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1.Young group, 25-45 years old, Elderly group:65-75 years old; healthy people.
2.No history of an adverse reaction to any of the components of the active or placebo versions of the probiotic product.
3.Can eat breakfast, lunch and dinner, regularly.
4.Has been diagnosed by doctors as healthy both physically and mentally (no diabetes etc).
5.Can abide by the experimental protocol.
Exclusion Criteria
1.Pregnant or lactating female or planning pregnancy during the study.
2.Unable to abstain from antibiotics or laxatives during the study.
3.History of GI surgery (except appendectomy).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of intestinal microbiota and intestinal environment <br/ ><br>ã?»Increase in beneficial bacteria (ex. Bifidobacterium) <br/ ><br>ã?»Decrease in harmful bacteria (C. perfringens, C. difficile, Vibrio cholerae/mimicus, Vibrio parahaemolyticus, Campylobacter jejuni/coli, Shigella spp, E. coli etc.) <br/ ><br>ã?»Increase in the amount of Short Chain Fatty Acids <br/ ><br>Timepoint: From day 36 to 91 subjects will drink either 1 bottle of placebo or 1 bottle of intervention agent and 5 fecal samples from each subjects will be collected and tested on/from day 49, 63, 77, 91 and 105. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Beneficial changes of score from questionnairesTimepoint: Questionnaires from each subject will be collected on/from day 49, 63, 77, 91 and 105. <br/ ><br>