Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Baylor College of Medicine40 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Irritable Bowel Syndrome Abdominal Pain

Interventions

Low fermentable substrate dietOTHER

Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.

High fermentable substrate dietOTHER

Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (2)

Children's Nutrition Research Center

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Average daily abdominal pain frequency

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.

Time frame: 9 days (2 dietary intervention periods)

Secondary Outcomes

Abdominal pain severity

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.

Time frame: 9 days (2 dietary intervention periods)

Hydrogen gas production

Daily hydrogen gas production (parts per million) will be compared between each 2 day dietary intervention period over 9 days.

Time frame: 9 days (2 dietary intervention periods)

Data from ClinicalTrials.gov

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