NCT06668922 Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
| NCT ID | NCT06668922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Irritable Bowel Syndrome (IBS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-11-28 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2024-11-28 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Frequently Asked Questions
Who can join the NCT06668922 clinical trial?
This trial is open to participants of all sexes, aged 17 Years or older, up to 65 Years, studying Irritable Bowel Syndrome (IBS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06668922 currently recruiting?
Yes, NCT06668922 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of California, Los Angeles to inquire about joining.
Where is the NCT06668922 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06668922 clinical trial?
NCT06668922 is sponsored by University of California, Los Angeles. The trial plans to enroll 72 participants.