Constipation Fiber Trial

September 26, 2017 updated by: Warren Bishop

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fiber 1
Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks
Other: Fiber
Other Names:
  • Blend of fiber types
Experimental: Fiber 2
Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks
Other: Fiber
Other Names:
  • Blend of fiber types
Placebo Comparator: Placebo
Bar with low fiber content (placebo) once daily for 4 weeks
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in stool frequency
Time Frame: 4 weeks
4 weeks
Change in stool consistency
Time Frame: 4 weeks
Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warren Bishop

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Actual)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 26, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201203734

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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