Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Constipation in Children
- Sponsor
- Warren Bishop
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in stool consistency
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Warren Bishop
MD
University of Iowa
Eligibility Criteria
Inclusion Criteria
- •2-16 years of age with functional constipation as defined based on the Rome III criteria
Exclusion 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)
Outcomes
Primary Outcomes
Change in stool consistency
Time Frame: 4 weeks
Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end
Change in stool frequency
Time Frame: 4 weeks