Dietary Fiber for Irritable Bowel Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to characterize regional intestinal fermentation physiology and determine how the response to fermentable dietary fiber differs between healthy individuals and individuals with irritable bowel syndrome (IBS). The study will use ingestible capsule technologies to directly measure intestinal gases and regional microbiome composition following low-fiber and high-fiber meal challenges.
The main questions it aims to answer are:
Does the change in regional intestinal gas levels following a fermentable-fiber challenge differ between participants with IBS and healthy controls? How are regional intestinal gas dynamics associated with microbiome composition, breath gases, serum short-chain fatty acids, glucose dynamics, metabolites, and gastrointestinal symptoms?
Researchers will compare participants with IBS to healthy controls to determine whether intestinal fermentation responses to dietary fiber differ between these populations.
Participants will:
Complete two study visits approximately one week apart. At one visit, participants will receive a low-fiber control meal, and at the other visit, they will receive the same base meal containing 15 g of inulin. The order of the two meals will be assigned at random.
Swallow an Atmo gas-sensing capsule to measure intestinal H2, CO2, and O2 and a CapScan capsule to collect regional intestinal fluid for microbiome analysis.
Undergo serial blood and breath sampling and gastrointestinal symptom assessments during each 8-hour study visit.
Complete stool and urine collections, dietary assessment, and continuous glucose monitoring before and/or after the study visits.
Who Is on the Research Team?
Sean P Spencer, MD PhD
Principal Investigator
Stanford University
Benjamin Good, PhD
Principal Investigator
Stanford University
Jonas Cremer, PhD
Principal Investigator
Stanford University
Michael Fischbach, PhD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for adults who either have irritable bowel syndrome (IBS) or are healthy, and are willing to eat specific meals, swallow capsule devices, and undergo blood, breath, stool, and urine tests. People with certain medical conditions or those unable to safely participate may be excluded.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Atmo Gas-Sensing Capsule
- CapScan Regional Fluid-Sampling Capsule
- Inulin
- Low-fiber control breakfast shake
Trial Overview
The study compares how people with IBS versus healthy individuals respond to a high-fiber meal (with inulin) versus a low-fiber meal. Participants swallow capsules that measure gut gases and collect samples to analyze digestion and microbiome changes after each type of meal.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The IBS cohort consists of individuals who meet Rome IV diagnostic criteria for irritable bowel syndrome. Participants complete two study visits approximately one week apart and receive both meal conditions in randomized order: low-fiber control followed by 15 g of inulin, or 15 g of inulin followed by low-fiber control. At each visit, participants consume the assigned standardized breakfast shake with the Atmo gas-sensing capsule at t=0 and ingest the CapScan regional sampling capsule at t=4 hours.
The Healthy cohort consists of individuals without a diagnosed chronic gastrointestinal disorder or ongoing gastrointestinal symptoms warranting clinical evaluation. Participants complete two study visits approximately one week apart and receive both meal conditions in randomized order: low-fiber control followed by 15 g of inulin, or 15 g of inulin followed by low-fiber control. At each visit, participants consume the assigned standardized breakfast shake with the Atmo gas-sensing capsule at t=0 and ingest the CapScan regional sampling capsule at t=4 hours.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
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