This trial is active, not recruiting.

Conditions irritable bowel syndrome, abdominal pain
Treatments low fermentable substrate diet, high fermentable substrate diet
Sponsor Baylor College of Medicine
Collaborator NASPGHAN Foundation
Start date January 2011
End date December 2016
Trial size 40 participants
Trial identifier NCT01339117, H-28050


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
High fermentable substrate diet provided for two days
high fermentable substrate diet
Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols
Low fermentable substrate diet provided for two days
low fermentable substrate diet
Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.

Primary Outcomes

Average daily abdominal pain frequency
time frame: 9 days (2 dietary intervention periods)

Secondary Outcomes

Abdominal pain severity
time frame: 9 days (2 dietary intervention periods)
Hydrogen gas production
time frame: 9 days (2 dietary intervention periods)

Eligibility Criteria

Male or female participants from 7 years up to 17 years old.

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

Additional Information

Official title Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
Principal investigator Bruno P Chumpitazi, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.