Clinical trial NCT01339117: Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
Official title: Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Abdominal Pain
Keywords: irritable bowel syndrome
children
chronic abdominal pain
recurrent abdominal pain
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: NASPGHAN Foundation
First posted: 2011-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average daily abdominal pain frequency
timeFrame: 9 days (2 dietary intervention periods)
Secondary outcomes:
measure: Abdominal pain severity
timeFrame: 9 days (2 dietary intervention periods)
measure: Hydrogen gas production
timeFrame: 9 days (2 dietary intervention periods)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Bruno P Chumpitazi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chumpitazi BP, Cope JL, Hollister EB, Tsai CM, McMeans AR, Luna RA, Versalovic J, Shulman RJ. Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Aug;42(4):418-27. doi: 10.1111/apt.13286. Epub 2015 Jun 24.