CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 168 enrolled
Drug / intervention
Elimination Dietbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00526903
NCT00526903Phase 2Completed

Recurrent Abdominal Pain in Children

Baylor College of Medicine·interventional·Posted Sep 10, 2007·Updated Mar 8, 2016

In Brief

A Phase 2 clinical trial evaluating Elimination Diet for Abdominal Pain and Irritable Bowel Syndrome. Completed, enrolled 168 participants across 1 site.

Detailed Summary

The purpose of this study is to: 1. To determine if fiber versus placebo improves symptoms in children with recurrent abdominal pain/irritable bowel syndrome. 2. To determine possible ways fiber or placebo improve(s) symptoms in children with recurrent abdominal pain/irritable bowel syndrome by carrying out gastrointestinal tests and questionnaires. Understanding how diet and fiber affect GI function potentially will benefit the large numbers of children with irritable bowel syndrome (IBS) and provide insight into prevention of IBS in at risk children. We expect that the results from these studies can be used to lessen significantly the huge financial burden to society caused by these chronic conditions. Consent will be obtained from the parent/guardian and assent from the child.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 10, 2007
Enrollment StartJan 1, 2009
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 18.8 years ago

Interventions

Elimination Dietbehavioral

Daily diet change for 8 days.