Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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High fermentable substrate diet

High fermentable substrate diet provided for two days

Group Type EXPERIMENTAL

High fermentable substrate diet

Intervention Type OTHER

Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols

Low fermentable substrate diet

Low fermentable substrate diet provided for two days

Group Type EXPERIMENTAL

Low fermentable substrate diet

Intervention Type OTHER

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

Interventions

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Low fermentable substrate diet

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

Intervention Type OTHER

High fermentable substrate diet

Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No