Irritable Bowel Syndrome and Control Volunteers: Diet Challenge

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06668922
Status
Recruiting
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Conditions

  • Irritable Bowel Syndrome (IBS)

Eligibility Criteria

Sex
ALL
Age
17 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Inulin — DIETARY_SUPPLEMENT
    Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.

Study Details

The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS). The central hypothesis of this study is that specific shifts in the GI microbiome composition correlate with altered colonic SCFAs and BAs and contribute to IBS symptoms. Primary aims include: (a) identifying GI microbiome signatures in IBS subtypes (IBS-C and IBS-D) and matched controls, and test if microbiome signatures in these groups correlate with fecal SCFAs and bacterial fermentation of an indigestible carbohydrate (inulin) after a dietary challenge (fecal inulin), and (b) determining if GI microbiome signatures in IBS subtypes and controls correlate with fecal BAs or markers of SCFA production (fecal SCFAs or inulin) and test if BAs correlate with fecal SCFAs or inulin. The target population is adults ages 18-65 years meeting Rome IV criteria for IBS (both diarrhea- and constipation-predominant, IBS-D and IBS-C) and asymptomatic controls. Primary outcomes will be fecal bile acid excretion and profile, short-chain fatty acid excretion and profile, colonic transit, and fecal microbiota. Secondary outcomes will be stool characteristics based on responses to validated bowel diaries. Stool samples will be collected from participants during the last 2 days of a 4-day 100 g fat diet and split into 3 samples for fecal microbiota, SCFA, and bile acid analysis.

Key Dates

Start date
Nov 28, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy volunteers
    Adults ages 18-65 years with no prior history of gastrointestinal diseases or symptoms.
  • Experimental: Irritable Bowel Syndrome Patients with Diarrhea (IBS-D)
    Patients with irritable bowel syndrome (IBS) with diarrhea, ages 18-65 years fulfilling Rome IV criteria for IBS.
  • Experimental: Irritable Bowel Syndrome Patients with Constipation (IBS-C)
    Patients with irritable bowel syndrome (IBS) with constipation, ages 18-65 years fulfilling Rome IV criteria for IBS.

Primary Outcome Measure

Total fecal bile acids [ Time Frame: 48 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Michelle Choy
[email protected]
(310) 825-8430
Andrea S Shin (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, Los Angeles· Los Angeles, CA

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