Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge
University of California, Los Angeles
72 participants
Nov 28, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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
Exclusion Criteria10
- Inflammatory bowel disease, celiac disease, or certain types of abdominal cancer, as well as those with thyroid or liver issues
- Abdominal surgery or abdominal radiation within 6 months of study participation, with an exception for C-section or gallbladder removal
- Use of any prescription, over the counter, or herbal medications known to affect gastrointestinal function or study interpretation, such as opioids, inflammatory drugs or certain antidepressants, within 6 months prior to study participation for healthy volunteers, or within 2 days of study participation for participants with IBS.
- An exception will be permitted for limited use of stable low doses of antidepressants for individuals who have been taking them for a period greater than one month.
- Rescue medication such as Bisacodyl (dulcolax) to relieve severe constipation and allow for stool collection will be permitted when needed.
- Use of Ozempic and Ozempic-type medications
- Pregnant or breastfeeding women
- Antibiotic use within 3 months of study participation
- Use of prebiotics or probiotics within the 2 weeks before the study initiation
- Regular tobacco use within the past 6 months
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06668922