Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

This study is currently recruiting participants.

Verified May 2013 by Baylor College of Medicine

Sponsor:

Collaborator:

NASPGHAN Foundation

Information provided by (Responsible Party):

Bruno Chumpitazi, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT01339117

First received: April 14, 2011

Last updated: May 11, 2013

Last verified: May 2013

History of Changes

Purpose

The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome.

Condition	Intervention
Irritable Bowel Syndrome Abdominal Pain	Other: Low fermentable substrate diet Other: High fermentable substrate diet

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

Average daily abdominal pain frequency [ Time Frame: 9 days (2 dietary intervention periods) ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Abdominal pain severity [ Time Frame: 9 days (2 dietary intervention periods) ] [ Designated as safety issue: No ]
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.
Hydrogen gas production [ Time Frame: 9 days (2 dietary intervention periods) ] [ Designated as safety issue: No ]
Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days.

Estimated Enrollment:	40
Study Start Date:	January 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	7 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must include all of the following:

Children between the ages of 7-17 years;
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;
Negative physician evaluation for an organic etiology of the pain within the past year

Exclusion Criteria:

Will include any of the following:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339117

Contacts

Contact: Cynthia Tsai

ct2@bcm.edu

Locations

United States, Texas
Children's Nutrition Research Center	Recruiting
Houston, Texas, United States, 77030
Contact: Cynthia M Tsai ct2@bcm.edu
Principal Investigator: Bruno P Chumpitazi, MD, MPH
Texas Children's Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Cynthia Tsai ct@bcm.edu
Principal Investigator: Bruno P Chumpitazi, MD, MPH

Sponsors and Collaborators

Baylor College of Medicine

NASPGHAN Foundation

Investigators

Principal Investigator:

Bruno P Chumpitazi, MD, MPH

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Bruno Chumpitazi, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT01339117 History of Changes
Other Study ID Numbers:	H-28050
Study First Received:	April 14, 2011
Last Updated:	May 11, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

irritable bowel syndrome
children
chronic abdominal pain
recurrent abdominal pain

Additional relevant MeSH terms:

Abdominal Pain
Irritable Bowel Syndrome
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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