A double-blind, randomized controlled trial of the effects of continuous intake of 1-kestose on defecation habits in children in kindergarte
Phase 2
- Conditions
- constipation
- Registration Number
- JPRN-UMIN000044252
- Lead Sponsor
- Center for Preventive Medical Sciences, Chiba University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
Not provided
Exclusion Criteria
1) Those who have a chronic illness and plan to start, end or change drug treatment during the trial period, or those who have a history of serious illness 2) Those who are allergic to test foods 3) Those who plan to start or end the intake of probiotics / prebiotics preparations or foods during the trial period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the number of defecation days per week (according to the questionnaire)
- Secondary Outcome Measures
Name Time Method Average number of defecation per week (according to a questionnaire) Fecal properties (by Bristol stool property scale / questionnaire) Changes in the intestinal flora in feces Changes in the number of copies of intestinal bacteria in feces Changes in short-chain fatty acids in feces Incidence of adverse events