Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

January 20, 2021 updated by: Bruno Chumpitazi, Baylor College of Medicine
The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many children experience stomach pain or discomfort at some point during their lives. Some children have belly discomfort frequently while others rarely have this problem. There have been very few studies to test treatments for recurrent stomach discomfort in children. Recently, studies in adults with recurrent stomach discomfort suggest that diet changes may help. Currently, we do not know if these same diets will work in children with the same problem.

In this study, two different diets will be provided (delivered) for two days with at least 5 days in between each provided diet. The child's symptoms will be recorded over the two days of each diet. Children will be asked to capture samples of their breath during the last day of the each two day delivered diet. Stool samples will also be collected.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • Houston, Texas, United States, 77030
        • Children's Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Must include all of the following:

  1. Children between the ages of 7-17 years;
  2. Meet the criteria for IBS based on the Questionnaire on Pediatric Gastrointestinal Symptoms Rome III Version, including pain/discomfort a minimum of twice per week;
  3. Negative physician evaluation for an organic etiology of the pain within the past year

Exclusion Criteria:

Will include any of the following:

  1. Diabetes or other disease process requiring specialized dietary management;
  2. Malnutrition or obesity (BMI >95%);
  3. Inability to eat by mouth;
  4. Antibiotic or medicinal probiotic usage within the past 3 months (excluding yogurt);
  5. Neuromodulator (e.g. amitriptyline) usage within the past 3 months
  6. Start of, or change in gastrointestinal medication (e.g. laxative) dose that may cause or ameliorate abdominal symptoms within the past month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High fermentable substrate diet
High fermentable substrate diet provided for two days
Other: High fermentable substrate diet
Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols
Experimental: Low fermentable substrate diet
Low fermentable substrate diet provided for two days
Other: Low fermentable substrate diet
Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average daily abdominal pain frequency
Time Frame: 9 days (2 dietary intervention periods)
Comparisons of abdominal pain frequency (number of abdominal pain episodes per day) will be made between each two day dietary period spanning a 9 days.
9 days (2 dietary intervention periods)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal pain severity
Time Frame: 9 days (2 dietary intervention periods)
The severity of abdominal pain episodes will be measured on a 1-10 (10 being most severe) ordinal scale. Average severity per abdominal pain episode during each two day dietary period will be compared over 9 days.
9 days (2 dietary intervention periods)
Hydrogen gas production
Time Frame: 9 days (2 dietary intervention periods)
Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days.
9 days (2 dietary intervention periods)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

NASPGHAN Foundation

Investigators

  • Principal Investigator: Bruno P Chumpitazi, MD, MPH, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-28050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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