Microbiome Fructan Metabolism and Symptoms in Childhood IBS



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:7 - 17
Updated:8/3/2017
Start Date:September 2014
End Date:December 2019
Contact:Adetola Vaughan
Email:adetola.vaughan@bcm.edu
Phone:832-822-3621

Use our guide to learn which trials are right for you!

Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS

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.

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.

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
We found this trial at
2
sites
Houston, Texas 77030
Principal Investigator: Bruno P Chumpitazi, MD, MPH
?
mi
from
Houston, TX
Click here to add this to my saved trials
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Bruno P Chumpitazi, MD, MPH
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
?
mi
from
Houston, TX
Click here to add this to my saved trials