Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency : A randomized, double blinded, placebo controlled study
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000028830
- Lead Sponsor
- TTC Co., Ltd.
- Brief Summary
The changes in stool frequency between the two periods in the per protocol population (n=58) were mean3.0 SD3.0 and mean1.6 SD2.9 times/2 weeks in B.coagulans-containing food group and placebo group, respectively (P=0.09). The intergroup difference was significant in the population (n=53) after excluding subjects who took an antibiotic or experienced a change in eating habit (mean3.0 SD3.0 and mean1.2 SD2.8 times/2 weeks in B.coagulans-containing food group and placebo group, respectively, P=0.03). No significant intergroup differences were found in the changes in stool properties, defecation amount, and intestinal flora pattern.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
(1)Subjects routinely taking medicine or health food which may influence bowel movement and take foods of lactic acid bacteria. (2) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative (3) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy) (4) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases (5) Subjects who are under medication or having a history of serious diseases for which medication was required (6) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (7) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality (8) Subjects having possibilities for emerging allergy related to the study (9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (10) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (13) Subjects judged as unsuitable for the study by the investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Defecation frequency,Defecation days. Evaluate at points of 2-week of consumption.
- Secondary Outcome Measures
Name Time Method Intestinal flora (T-RFLP, Real-Time PCR), Stool output, Fecal condition, Questionnaire