MedPath

Effect of Lactobacillus brevis KB290(heat-killed) on bowel movement and on microbiota in subjects with a tendency toward constipation.

Not Applicable
Conditions
people tend to be constipated
Registration Number
JPRN-UMIN000034038
Lead Sponsor
Kagome Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

Exclusion Criteria

1)Who regularly consumes some food containing viable bacteria such as yorgurt, fermented beverage with lactic acid bacteria, natto, kimchi, and tsukemono (excluding those who can stop the consumption during this study). 2)Who cannot stop to use/intake a drug (e.g. intestinal drugs and laxatives), health foods, Food for Specified Health Uses, Foods with Function Claims, health food, dietary supplements and other supplements, and/or foods enhanced with oligosaccharide or dietary fiber. 3)Who has bowel movement illness and go to a hospital regularly, and on medication, or using over-the-counter laxatives. 4)Who has receive medical treatments for gastrointestinal diseases that affect regulation of intestinal function, or a history of those (except for appendicectomy). 5)Who has such diseases as irritable bowel syndrome or ulcerative colitis that significantly affect bowel movements, or a history of those. 6)Who has such diseases as diabetes, liver diseases, kidney diseases, heart diseases, or a history of those. 7)Who is on exercise or diet therapy under the direction of a physician. 8)Who has diseases requiring continuous medication. 9)Who has a history of serious disease requiring medication. 10)Who has allergic to drug or food. 11)Who are judged as unsuitable for this study based on subject questionnaire. 12) Who is judged as unsuitable for this study based on the results of physical and clinical examination on screening test. 13)Who is pregnant or breast-feeding or willing to be pregnant during this study. 14)Who has a mental disorders (e.g. depression) or a history of that. 15)Who is employed on night or on shift work. 16)Who has a current or history of drug dependence or drug abuse. 17)Who has participated in other clinical study within the last three months prior to the date of consent to participating on this study, or willing to be that. 18)Who is judged unsuitable for this study by principal investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Defecation frequency and days of defecation. The value and changes after intervention treatment will be compared between each test beverages.
Secondary Outcome Measures
NameTimeMethod
Amount of defecation, Bristol Stool Form Scale, stool color and smell, feeling after defecation, fecal microbiota. The value and changes after intervention treatment will be compared between each test beverages.
© Copyright 2025. All Rights Reserved by MedPath