Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Study Overview
=================
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.

Official Title
-----------------
Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome, Abdominal Pain

Intervention / Treatment
-----------------
* Other: Low fermentable substrate diet
* Other: High fermentable substrate diet


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High fermentable substrate diet<br>High fermentable substrate diet provided for two days | Other: High fermentable substrate diet<br>* Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols<br>|
| Experimental: Low fermentable substrate diet<br>Low fermentable substrate diet provided for two days | Other: Low fermentable substrate diet<br>* Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 days (2 dietary intervention periods) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 9 days (2 dietary intervention periods) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent abdominal pain, irritable bowel syndrome, children, chronic abdominal pain