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Constipation Fiber Trial

NCT ID: NCT02193997

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Functional Constipation in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fiber 1

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

Group Type EXPERIMENTAL

Fiber

Intervention Type OTHER

Fiber 2

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

Group Type EXPERIMENTAL

Fiber

Intervention Type OTHER

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Fiber

Intervention Type OTHER

Fiber

Intervention Type OTHER

Placebo

Intervention Type OTHER

Other Intervention Names

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Single fiber type Blend of fiber types

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Warren Bishop

OTHER

Sponsor Role lead

Responsible Party

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Warren Bishop

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Warren Bishop, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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201203734

Identifier Type: -

Identifier Source: org_study_id