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Microbiome Fructan Metabolism and Symptoms in Childhood IBS

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ClinicalTrials.gov Identifier: NCT02842281
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Bruno Chumpitazi, 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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome (IBS) Other: Fructan Other: Maltodextrin Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS
Study Start Date : September 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: Fructan
Fructans will be provided for 72 hours.
Other: Fructan
Short-chain oligosaccharide primarily composed of fructose polymers
Other Name: fructo-oligosaccharides

Placebo Comparator: Maltodextrin
Maltodextrin will be provided for 72 hours.
Other: Maltodextrin
Polysaccharide produced from starch




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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)


Secondary Outcome Measures :
  1. 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

  2. Overall microbiome metabolic signatures [ Time Frame: Three days ]
    Children with IBS who have worsening GI symptoms vs. those who do not

  3. 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

  4. 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



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842281


Contacts
Contact: Adetola Vaughan 832-822-3621 adetola.vaughan@bcm.edu

Locations
United States, Texas
Children's Nutrition Research Center Recruiting
Houston, Texas, United States, 77030
Contact: Adetola Vaughan       adetola.vaughan@bcm.edu   
Principal Investigator: Bruno P Chumpitazi, MD, MPH         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Adetola Vaughan       adetola.vaughan@bcm.edu   
Principal Investigator: Bruno P Chumpitazi, MD, MPH         
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Bruno Chumpitazi, MD, MPH Assistant Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruno Chumpitazi, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02842281     History of Changes
Other Study ID Numbers: H-34372
K23DK101688 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Levan
Antineoplastic Agents