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Irritable Bowel Syndrome | Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

Irritable Bowel Syndrome research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Irritable Bowel Syndrome

Abdominal Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Low fermentable substrate dietDiet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.

Other:High fermentable substrate dietDiet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

High fermentable substrate dietHigh fermentable substrate diet provided for two days

Low fermentable substrate dietLow fermentable substrate diet provided for two days

Study Status

Active, not recruiting

Start Date: January 2011

Completed Date: December 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Average daily abdominal pain frequency

Secondary Outcome: Abdominal pain severity

Study sponsors, principal investigator, and references

Principal Investigator: Bruno P Chumpitazi, MD, MPH

Lead Sponsor: Baylor College of Medicine

Collaborator: NASPGHAN Foundation

More information:https://clinicaltrials.gov/show/NCT01339117

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