Dietary Fiber for Irritable Bowel Syndrome

JT
RS
Overseen ByRoujheen Sabetan, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

SP

Sean P Spencer, MD PhD

Principal Investigator

Stanford University

BG

Benjamin Good, PhD

Principal Investigator

Stanford University

JC

Jonas Cremer, PhD

Principal Investigator

Stanford University

MF

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

I have IBS diagnosed by Rome IV criteria and a previous hydrogen/methane breath test result.
I have never had a chronic digestive disorder or ongoing digestive symptoms.
I am able and willing to attend virtual and in-person study visits.
See 3 more

Exclusion Criteria

I have had surgery that changed my digestive tract structure.
I have used antibiotics, probiotics, or prebiotics in the past 4 weeks.
I have a gastric bezoar (a mass in my stomach).
See 16 more

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

Group I: Irritable Bowel Syndrome (IBS)Experimental Treatment4 Interventions
Group II: Healthy controlsExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+