Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Sponsor

Baylor College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01339117

Collaborator

NASPGHAN Foundation (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome Abdominal Pain	Other: Low fermentable substrate diet Other: High fermentable substrate diet	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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