Microbiome Fructan Metabolism and Symptoms in Childhood IBS

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome (IBS)
• Interventions: Other: Maltodextrin; Other: Fructan

• Registration Number: NCT02842281
• Lead Sponsor: Baylor College of Medicine

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-22
• Primary Completion: 2019-03
• Study Completion: 2019-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Maltodextrin	Maltodextrin will be provided for 72 hours.
Fructan	Fructan	Fructans will be provided for 72 hours.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Breath hydrogen and methane production symptoms	Three days	Children with IBS who have worsening GI symptoms when given fructans vs. those who do not
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
Overall metabolic products	Three days	Following a fructan challenge in children with IBS who develop worsening GI symptoms vs. those who do not
Overall microbiome metabolic signatures	Three days	Children with IBS who have worsening GI symptoms vs. those who do not

Trial Locations

Locations (2)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Children's Nutrition Research Center; 🇺🇸 Houston, Texas, United States