Clinical trial NCT02842281: Microbiome Fructan Metabolism and Symptoms in Childhood IBS
Official title: Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome (IBS)
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-07-22
Enrollment: 55
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing)
timeFrame: Three days
measure: Microbiome metabolic signatures related to fructan metabolism
timeFrame: Three days
measure: Metabolic products of fructan metabolism
timeFrame: Three days
Secondary outcomes:
measure: Microbiome related signatures
timeFrame: Three days
measure: Overall microbiome metabolic signatures
timeFrame: Three days
measure: Overall metabolic products
timeFrame: Three days
measure: Breath hydrogen and methane production symptoms
timeFrame: Three days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Assistant Professor
name: Bruno Chumpitazi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chumpitazi BP, McMeans AR, Vaughan A, Ali A, Orlando S, Elsaadi A, Shulman RJ. Fructans Exacerbate Symptoms in a Subset of Children With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2018 Feb;16(2):219-225.e1. doi: 10.1016/j.cgh.2017.09.043. Epub 2017 Sep 29.