Microbiome Fructan Metabolism and Symptoms in Childhood IBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Carbohydrates in Irritable Bowel Syndrome

NCT04830410

Irritable Bowel Syndrome With Diarrhea

COMPLETED NA

Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome

NCT01018498

Irritable Bowel Syndrome

COMPLETED NA

Delivered Dietary Intervention for Children With Irritable Bowel Syndrome

NCT01339117

Irritable Bowel Syndrome Abdominal Pain

COMPLETED NA

Diet and Motility in IBS

NCT07283341

Irritable Bowel Syndrome (IBS)

RECRUITING

Brain and Gut Responses to Intragastric Administration of FODMAPs in Healthy Subjects and Patients With Irritable Bowel Syndrome

NCT04283487

Irritable Bowel Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome (IBS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fructan

Fructans will be provided for 72 hours.

Group Type ACTIVE_COMPARATOR

Fructan

Intervention Type OTHER

Short-chain oligosaccharide primarily composed of fructose polymers

Maltodextrin

Maltodextrin will be provided for 72 hours.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type OTHER

Polysaccharide produced from starch

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fructan

Short-chain oligosaccharide primarily composed of fructose polymers

Intervention Type OTHER

Maltodextrin

Polysaccharide produced from starch

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

fructo-oligosaccharides

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes