Constipation Fiber Trial

N/ACompletedNCT02193997

Warren Bishop60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Functional Constipation in Children

Interventions

FiberOTHER

PlaceboOTHER

Eligibility

Sex: ALLMin age: 2 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Iowa

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Change in stool frequency

Time frame: 4 weeks

Change in stool consistency

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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