NCT02193997

Constipation Fiber Trial

Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Warren Bishop · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Functional Constipation in Children

Interventions

Type	Name	Description
OTHER	Fiber
OTHER	Fiber
OTHER	Placebo

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-07-18
• Last updated: 2017-09-28

Locations

1 site across 1 country: United States