Evaluation of the efficacy of dietary fiber-containing food on gastrointestinal condition : a double blind, randomized, placebo controlled, crossover study
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000031693
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1) Subjects who regularly use laxatives 2) Subjects who regularly take foods which may affect gastrointestinal condition 3) Subjects who regularly use antibiotics and other medicines which affect digestion and absorption 4) Subjects who cannot abstain from taking foods which are containing viable bacteria, enriched with oligosaccharides or dietary fiber, considered effective for constipation improvement and are containing large amount of sugar alcohol 5) Subjects who have allergy for foods 6) Subjects who regularly take too much alcohol 7) Subjects who have diseases which require urgent treatment or severe complications 8) Subjects who have gastrointestinal diseases or a surgical history which may affect digestion, absorption and defecation 9) Subjects who are pregnant, lactating or planning to be pregnant in the test period 10) Subjects who are under treatment or have a history of drug addiction or alcoholism 11) Subjects who are participating or planning to participate in a clinical study 12) Subjects who are judged as inappropriate by investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber and ratio of fecal Bifidobacterium Defecation frequency
- Secondary Outcome Measures
Name Time Method Defecation days, stool volume, stool shape, stool color, stool smell and the feeling after defecation Intestinal microflora analysis Fecal ammonia measurement Fecal pH measurement Fecal water content measurement Stool weight