Constipation Fiber Trial
- Conditions
- Functional Constipation in Children
- Interventions
- Other: FiberOther: Placebo
- Registration Number
- NCT02193997
- Lead Sponsor
- Warren Bishop
- Brief Summary
This study examines the effects of dietary fiber in the treatment of functional childhood constipation.
- Detailed Description
This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary fiber in treating functional childhood constipation. The addition of fiber is anticipated to allow children to have more normal stool consistency and frequency.
All participants will be asked to take a snack bar twice daily and will be randomized in a 1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked to take low-dose Miralax to avoid worsening of constipation in all groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 2-16 years of age with functional constipation as defined based on the Rome III criteria
- Constipation attributable to organic and anatomic causes or intake of medication
- Children who had previous surgery of the colon or anus
- History of allergy/intolerance to components of snack bar (e.g. celiac disease)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fiber 1 Fiber Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks Fiber 2 Fiber Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks Placebo Placebo Bar with low fiber content (placebo) once daily for 4 weeks
- Primary Outcome Measures
Name Time Method Change in stool consistency 4 weeks Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end
Change in stool frequency 4 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Iowa
🇺🇸Iowa City, Iowa, United States