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Constipation Fiber Trial

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ClinicalTrials.gov Identifier: NCT02193997
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Warren Bishop, University of Iowa

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

Condition or disease Intervention/treatment Phase
Functional Constipation in Children Other: Fiber Other: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation
Actual Study Start Date : June 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fiber 1
Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks
Other: Fiber
Other Name: Single fiber type

Experimental: Fiber 2
Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks
Other: Fiber
Other Name: Blend of fiber types

Placebo Comparator: Placebo
Bar with low fiber content (placebo) once daily for 4 weeks
Other: Placebo



Primary Outcome Measures :
  1. Change in stool frequency [ Time Frame: 4 weeks ]
  2. Change in stool consistency [ Time Frame: 4 weeks ]
    Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end



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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193997


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Warren Bishop
Investigators
Principal Investigator: Warren Bishop, MD University of Iowa

Responsible Party: Warren Bishop, MD, University of Iowa
ClinicalTrials.gov Identifier: NCT02193997     History of Changes
Other Study ID Numbers: 201203734
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms