Effect of Lactobacillus brevis KB290 on bowel movement and on intestinal environment in subjects with a tendency toward constipation: a randomized, double-blind, placebo-controlled, cross-over trial.
- Conditions
- People tend to be constipated
- Registration Number
- JPRN-UMIN000024691
- Lead Sponsor
- Kagome Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
Not provided
People who meet any of the following conditions will be excluded. 1) Who regularly use intestinal drugs and laxatives (including strong laxatives and enema). 2) Who can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during this study. 3) Who habitually consume higher amount of alcohol (more than 1000 mL in terms of beer per day). 4) Who use medicine such as antibiotics that affect digestion and absorption. 5) Who have allergic to food. 6) Who is pregnant or willing to be pregnant or breast-feeding during this study. 7) Who are participated in other clinical trials that intake/apply any of food, drug, and cosmetics, or willing to be that. 8) Who have serious diseases requiring an urgent treatment, or who accept severe complication. 9) Who has a medical history of diseases or surgeries affecting digestion, absorption and bowel movement (except for appendicectomy). 10) Who has a current or history of drug dependence and/or alcoholism. 11) Who has ever been diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD). 12) Who has an irregular menstrual cycle, or is undergoing treatment for menopause. 13) Who are judged unsuitable for this study based on subject questionnaire. 14) Who are judged unsuitable for this study by principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Defecation frequency and days of defecation. The value and changes after intervention treatment will be measured, and compared between each test drinks.
- Secondary Outcome Measures
Name Time Method Amount of defecation, Bristol Stool Form Scale, stool color and smell, feeling after defecation will be measured. Also, Bifidobacterium occupancy and other variety and ratio of bacteria in stool (intestinal microbiota), fecal organic acid concentration will be measured. The changes will be compared between each test drinks.