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NCT06668922 · ClinicalTrials.gov registry record · NA
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
A NA study of Irritable Bowel Syndrome (IBS), sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT06668922 is a NA study of Irritable Bowel Syndrome (IBS) that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 72 participants, below the 1,174-participant average among 5 other Irritable Bowel Syndrome (IBS) trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06668922, a NA study of Irritable Bowel Syndrome (IBS), is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Inulin
Study Locations (1)
California
- University of California, Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-11-28 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06668922
The ClinicalTrials.gov registry entry for NCT06668922 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,174-participant average among 5 other Irritable Bowel Syndrome (IBS) trials with a reported enrollment target (94% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Irritable Bowel Syndrome (IBS) appearing as the primary indexed condition, and to 1 intervention - of which Inulin is the first listed.
NCT06668922 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06668922 about?
NCT06668922 is a clinical study titled "Irritable Bowel Syndrome and Control Volunteers: Diet Challenge". 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 ...
What is the current status of trial NCT06668922?
This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2024-11-28. Estimated completion is 2030-12-31.
What conditions does trial NCT06668922 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome (IBS).
What interventions are being tested in trial NCT06668922?
The interventions under investigation include: Inulin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06668922?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06668922 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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