MedPath

The effects of bifidobacterium lactis strain NT and effects of addition to galacto-oligosaccharide on defecation frequency in healthy subjects with low defecation frequency: a randomized, double-blind, placebo-controled, parallel-group trial

Not Applicable
Conditions
Subjects who have a tendency to be constipated
Registration Number
JPRN-UMIN000033185
Lead Sponsor
Second Lecture of Internal Medicine, Wakayama Medical University School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
69
Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects diagnosed with constipation or subjects who fit the Rome IV criteria in the interview 2. Subjects who have the history of organic disease in the gastrointestinal tract in the past and present 3. Subjects who diagnosed as kidney disease 4. Subjects who diagnosed as diabetes 5. Subjects who diagnosed with hypothyroidism 6. Subjects who diagnosed with inflammatory disease 7. Subjects who diagnosed with neurological or psychiatric disease 8. Subjects who took antibiotics or probiotics within the past 1 month including present 9. Subjects who take the drugs inducing chronic constipation 10. Subjects who use biological drugs and steroids 11. Subject who take the foods containing lactic acid bacteria or bifidus bacteria routinely 12. Subject who take the health food for constipation improvement routinely 13. Subjects who have a history of allergy to the foods containing lactobacillus or bifidus bacteria 14. Subjects who participating in other clinical tests about food containing probiotics, or who have not been past one month since participation 15. Subjects who cannot stop the use of constipation drugs and that of foods for constipation improvement during the research period 16. Subjects who will travel overseas during the research period 17. Subjects who investigator judge not suitable to participate in the trial

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Frequency of spontaneous bowel movements during the second week of the administration period
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath