Microbiome Fructan Metabolism and Symptoms in Childhood IBS

Irritable Bowel Syndrome (IBS) Clinical Trial

Official title:

Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842281
• Other study ID #: H-34372
• Secondary ID: K23DK101688
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2019

Study information

• Verified date: January 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)

Intervention

Other:
• Fructan
Short-chain oligosaccharide primarily composed of fructose polymers
• Maltodextrin
Polysaccharide produced from starch

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Microbiome metabolic signatures related to fructan metabolism	Children with IBS who have worsening GI symptoms with fructans vs. those who do not	Three days
Primary	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	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	Three days
Secondary	Overall microbiome metabolic signatures	Children with IBS who have worsening GI symptoms vs. those who do not	Three days
Secondary	Overall metabolic products	Following a fructan challenge in children with IBS who develop worsening GI symptoms vs. those who do not	Three days
Secondary	Breath hydrogen and methane production symptoms	Children with IBS who have worsening GI symptoms when given fructans vs. those who do not	Three days