Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Abdominal Pain; Irritable Bowel Syndrome
• Interventions: Other: High fermentable substrate diet; Other: Low fermentable substrate diet

• Registration Number: NCT01339117
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High fermentable substrate diet	High fermentable substrate diet	High fermentable substrate diet provided for two days
Low fermentable substrate diet	Low fermentable substrate diet	Low fermentable substrate diet provided for two days

Primary Outcome Measures

Name	Time	Method
Average daily abdominal pain frequency	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.

Secondary Outcome Measures

Name	Time	Method
Abdominal pain severity	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.
Hydrogen gas production	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.

Trial Locations

Locations (2)

Children's Nutrition Research Center; 🇺🇸 Houston, Texas, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States