- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02842281
Microbiome Fructan Metabolism and Symptoms in Childhood IBS
Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Houston, Texas, United States, 77030
- Children's Nutrition Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Investigators
- Principal Investigator: Bruno Chumpitazi, MD, MPH, Assistant Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
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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