Clinical Trials Directory

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

TypeNameDescription
OTHERFructanShort-chain oligosaccharide primarily composed of fructose polymers
OTHERMaltodextrinPolysaccharide 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.