Constipation Fiber Trial

Functional Constipation in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193997
• Other study ID #: 201203734
• Status: Completed
• Phase: N/A
• First received: June 24, 2014
• Last updated: September 26, 2017
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: September 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the effects of dietary fiber in the treatment of functional childhood constipation.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constipation
• Functional Constipation in Children

Intervention

Other:
• Fiber

• Fiber

• Placebo

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Warren Bishop

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stool frequency		4 weeks
Primary	Change in stool consistency	Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end	4 weeks