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Constipation Fiber Trial

Primary Purpose

Functional Constipation in Children

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fiber

Placebo

About this trial

This is an interventional treatment trial for Functional Constipation in Children

Eligibility Criteria

2 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Fiber 1

Fiber 2

Placebo

Arm Description

Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks

Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks

Bar with low fiber content (placebo) once daily for 4 weeks

Outcomes

Primary Outcome Measures

Change in stool frequency

Change in stool consistency

Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end

Secondary Outcome Measures

Full Information

NCT ID

NCT02193997

First Posted

June 24, 2014

Last Updated

September 26, 2017

Sponsor

Warren Bishop

1. Study Identification

Unique Protocol Identification Number

NCT02193997

Brief Title

Constipation Fiber Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

June 2012 (Actual)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Warren Bishop

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Constipation in Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fiber 1

Arm Type

Experimental

Arm Description

Fiber bar containing inulin as fiber soucre taken once daily for 4 weeks

Arm Title

Fiber 2

Arm Type

Experimental

Arm Description

Fiber bar containing soluble corn as fiber soucre taken once daily for 4 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Bar with low fiber content (placebo) once daily for 4 weeks

Intervention Type

Other

Intervention Name(s)

Fiber

Other Intervention Name(s)

Single fiber type

Intervention Type

Other

Intervention Name(s)

Fiber

Other Intervention Name(s)

Blend of fiber types

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in stool frequency

Time Frame

4 weeks

Title

Change in stool consistency

Description

Stool consistency (using the Bristol scale) will be compared between groups, between baseline and study end

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Warren Bishop, MD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

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Constipation Fiber Trial

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