A study for evaluating the effects of oral intake of food containing lactic acid bacteria on bowel movement of subjects with a tendency for constipation. A randomized, double-blind, placebo-controlled trial.
- Conditions
- Subjects with a tendency for constipation
- Registration Number
- JPRN-UMIN000022263
- Lead Sponsor
- KSO Corporation
- Brief Summary
Jpn Pharmacol Ther 2017; 45(3): 463-472.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
(1) Individuals taking antiflatulents and/or laxatives (including purgative drug) in common use (2) Individuals taking health foods in common use, including food for specified health use, which influence intestinal regulation at the point of screening examination (3) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use at the point of screening examination (4) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use, which influence intestinal regulation during the study period (5) Individuals presenting known food allergy (6) Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications (7) Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (8) Individuals who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire (9) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (10) Individuals who are under treatment or have a history of drug/alcohol dependence (11) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (12) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Defecation days, defecation frequency, fecal amount
- Secondary Outcome Measures
Name Time Method Fecal shape, fecal color, fecal odor, feeling after defecation, fecal organic acids, fecal ammonia content, fecal pH, fecal water content, analysis of intestinal microflora