Constipation Fiber Trial

Not Applicable

Completed

• Conditions: Functional Constipation in Children

• 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-06-24
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States