Microbiome Fructan Metabolism and Symptoms in Childhood IBS

January 20, 2021 updated by: Bruno Chumpitazi, Baylor College of Medicine

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • Houston, Texas, United States, 77030
        • Children's Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fructan
Fructans will be provided for 72 hours.
Short-chain oligosaccharide primarily composed of fructose polymers
Other Names:
  • fructo-oligosaccharides
Placebo Comparator: Maltodextrin
Maltodextrin will be provided for 72 hours.
Polysaccharide produced from starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing)
Time Frame: Three days
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Three days
Microbiome metabolic signatures related to fructan metabolism
Time Frame: Three days
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Three days
Metabolic products of fructan metabolism
Time Frame: 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)
Three days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bruno Chumpitazi, MD, MPH, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • H-34372
  • K23DK101688 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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