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Completed

NCT Number: NCT02842281

Microbiome Fructan Metabolism and Symptoms in Childhood IBS

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Nutrition Research Center, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fructan

Other

Short-chain oligosaccharide primarily composed of fructose polymers

Other names: fructo-oligosaccharides

maltodextrin

Other

Polysaccharide produced from starch

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Intestinal Microbiome Fructan Metabolism and Symptom Generation in Childhood IBS

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2016
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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