NCT02842281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

4.5 years

First QC Date

July 15, 2016

Last Update Submit

January 20, 2021

Conditions

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (3)

  • 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

    Three days

  • Microbiome metabolic signatures related to fructan metabolism

    Children with IBS who have worsening GI symptoms with fructans vs. those who do not

    Three days

  • 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)

    Three days

Secondary Outcomes (4)

  • Microbiome related signatures

    Three days

  • Overall microbiome metabolic signatures

    Three days

  • Overall metabolic products

    Three days

  • Breath hydrogen and methane production symptoms

    Three days

Study Arms (2)

Fructan

ACTIVE COMPARATOR

Fructans will be provided for 72 hours.

Other: Fructan

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin will be provided for 72 hours.

Other: Maltodextrin

Interventions

FructanOTHER

Short-chain oligosaccharide primarily composed of fructose polymers

Also known as: fructo-oligosaccharides
Fructan
MaltodextrinOTHER

Polysaccharide produced from starch

Maltodextrin

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 28970147DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fructansfructooligosaccharidemaltodextrin

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PolysaccharidesCarbohydrates

Study Officials

  • Bruno Chumpitazi, MD, MPH

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 22, 2016

Study Start

September 1, 2014

Primary Completion

March 1, 2019

Study Completion

December 1, 2019

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Locations

US(2)