Trials / Completed
CompletedNCT02842281
Microbiome Fructan Metabolism and Symptoms in Childhood IBS
Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Baylor College of Medicine · Academic / Other
- Sex
- All
- Age
- 7 Years – 17 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Fructan | Short-chain oligosaccharide primarily composed of fructose polymers |
| OTHER | Maltodextrin | Polysaccharide produced from starch |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2019-03-01
- Completion
- 2019-12-01
- First posted
- 2016-07-22
- Last updated
- 2021-01-22
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02842281. Inclusion in this directory is not an endorsement.