Irritable Bowel Syndrome (IBS)
Conditions
Brief summary
This study evaluates whether the gut microbiome is involved in determining whether children with irritable bowel syndrome (IBS) develop worsening GI symptoms (e.g. pain) when given fructans (a sugar often found in wheat). Participants will both receive a diet with fructans and a diet without fructans.
Detailed description
Fructans (fructo-oligosaccharides) are a type of carbohydrate which can not be hydrolyzed by humans. It is commonly found in wheat in the American diet. After ingestion they arrive essentially intact into the colon where they are metabolized by the colonic microbiome. Fructan avoidance has been found to help decrease gastrointestinal symptoms (e.g. pain) in those with IBS. However not all individuals with IBS have worsening symptoms when eating fructans in their diet. This study seeks to evaluate whether the microbiome is involved in determining whether an individual with IBS has worsening symptoms with fructan ingestion. Following a one week baseline period, participants will be randomized in a double-blind cross-over fashion to either a 72 hour meal period with fructans or a 72 hour meal period with maltodextrin (placebo). A washout period of at least 10 days will occur in between. Symptoms will be captured using a stool and pain diary. Stool specimens and urine specimens will be obtained at baseline and during the dietary interventions. Breath hydrogen testing will be obtained during the dietary interventions.
Interventions
OTHERFructan
Short-chain oligosaccharide primarily composed of fructose polymers
OTHERMaltodextrin
Polysaccharide produced from starch
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Children ages 7-17 years * Children with IBS will meet Rome III criteria per the Rome III questionnaire * Healthy children will not have chronic conditions * English speaking and able to read/write in English
Exclusion criteria
* Previous bowel surgery * Documented gastrointestinal disorder (e.g. ulcerative colitis) * Serious chronic medical condition (e.g. diabetes) * Weight and/or height are greater than or less than 2 standard deviations for age * Chronic conditions with GI symptoms (e.g. cystic fibrosis) * Antibiotics within the past 3 months * Pregnancy * Autism spectrum disorder and/or significant developmental delay * Mood disorders (e.g. major depression) * Known post-infectious etiology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing) | Three days | Children with IBS who have worsening GI symptoms with fructans vs. those who do not |
| Microbiome metabolic signatures related to fructan metabolism | Three days | Children with IBS who have worsening GI symptoms with fructans vs. those who do not |
| Metabolic products of fructan metabolism | Three days | In those with IBS who have worsening symptoms when given fructans, the investigators will correlate fructan metabolic byproducts with GI symptoms (e.g. pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome related signatures | Three days | Healthy children will have their microbiome signatures (composition, metabolic signatures related to fructan metabolism, and metabolic products of fructan metabolism) compared to children with IBS |
| Breath hydrogen and methane production symptoms | Three days | Children with IBS who have worsening GI symptoms when given fructans vs. those who do not |
| Overall microbiome metabolic signatures | Three days | Children with IBS who have worsening GI symptoms vs. those who do not |
| Overall metabolic products | Three days | Following a fructan challenge in children with IBS who develop worsening GI symptoms vs. those who do not |
Countries
United States
Outcome results
None listed