Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 17
Maximum Age: 65
Healthy Volunteers: t
View:

• Age 18-75

• Individuals with irritable bowel syndrome (IBS)

• Healthy volunteers (healthy controls) with no prior history of gastrointestinal (GI) disease or symptoms

• No dietary restrictions other than vegetarian

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
Time Frame
Start Date: 2024-11-28
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 72
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov

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