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Microbiome Fructan Metabolism and Symptoms in Childhood IBS

Primary Purpose

Irritable Bowel Syndrome (IBS)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fructan
Maltodextrin
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Irritable Bowel Syndrome (IBS)

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Nutrition Research Center
  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fructan

Maltodextrin

Arm Description

Fructans will be provided for 72 hours.

Maltodextrin will be provided for 72 hours.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
July 15, 2016
Last Updated
January 20, 2021
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02842281
Brief Title
Microbiome Fructan Metabolism and Symptoms in Childhood IBS
Official Title
Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fructan
Arm Type
Active Comparator
Arm Description
Fructans will be provided for 72 hours.
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Maltodextrin will be provided for 72 hours.
Intervention Type
Other
Intervention Name(s)
Fructan
Other Intervention Name(s)
fructo-oligosaccharides
Intervention Description
Short-chain oligosaccharide primarily composed of fructose polymers
Intervention Type
Other
Intervention Name(s)
Maltodextrin
Intervention Description
Polysaccharide produced from starch
Primary Outcome Measure Information:
Title
Operational Taxonomic Units (microbiome composition derived from 16s rRNA sequencing)
Description
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Time Frame
Three days
Title
Microbiome metabolic signatures related to fructan metabolism
Description
Children with IBS who have worsening GI symptoms with fructans vs. those who do not
Time Frame
Three days
Title
Metabolic products of fructan metabolism
Description
In those with IBS who have worsening symptoms when given fructans, the investigators will correlate fructan metabolic byproducts with GI symptoms (e.g. pain)
Time Frame
Three days
Secondary Outcome Measure Information:
Title
Microbiome related signatures
Description
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
Time Frame
Three days
Title
Overall microbiome metabolic signatures
Description
Children with IBS who have worsening GI symptoms vs. those who do not
Time Frame
Three days
Title
Overall metabolic products
Description
Following a fructan challenge in children with IBS who develop worsening GI symptoms vs. those who do not
Time Frame
Three days
Title
Breath hydrogen and methane production symptoms
Description
Children with IBS who have worsening GI symptoms when given fructans vs. those who do not
Time Frame
Three days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Chumpitazi, MD, MPH
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Nutrition Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28970147
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.
Results Reference
derived

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Microbiome Fructan Metabolism and Symptoms in Childhood IBS

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