Abdominal Pain, Irritable Bowel Syndrome
Conditions
Keywords
irritable bowel syndrome, children, chronic abdominal pain, recurrent abdominal pain
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.
Interventions
OTHERLow fermentable substrate diet
Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.
OTHERHigh fermentable substrate diet
Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols
Sponsors
NASPGHAN Foundation
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed