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NCT05155631: U54_P3_CBT
Sex Differences in Effectiveness of CBT on IBS Project 3
NA trial testing COGNITIVE BEHAVIORAL THERAPY in IBS - Irritable Bowel Syndrome in 92 participants. Completed in 1 January 2025.
12 December 2024
Quick facts
| Lead sponsor | University of California, Los Angeles |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 92 |
| Start date | 18 December 2021 |
| Primary completion | 12 December 2024 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- COGNITIVE BEHAVIORAL THERAPY
Conditions studied
- IBS - Irritable Bowel Syndrome — all drugs for IBS - Irritable Bowel Syndrome →
Sponsor
University of California, Los Angeles
Who can join
Adults 18 to 55, any sex, with IBS - Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cognitive Behavioral Therapy (CBT) is the most well researched and most effective treatment for IBS targeting the brain-gut-microbiome (BGM) axis, and preliminary data show that this therapeutic effect is associated with a reduction of brainstem connectivity with other brain networks. The increased prevalence of IBS in women, the higher rate of comorbid non-GI pain conditions, as well as the higher prevalence in female IBS of increased sensitivity to a variety of internal and external stimuli (multisensory sensitivity) suggest the presence of important sex differences in some of these BGM mechanisms. Research performed by UCLA SCOR during previous funding has established an increased responsiveness of the CRF-Locus Coeruleus (LCC) system in female IBS subjects, suggesting that this central noradrenergic brainstem system plays an important role in IBS pathophysiology. In addition, the study team's earlier research has begun to identify clinical, functional and structural brain mechanisms that may underlie these sex effects. Based on the preliminary data, the overall goal of this project is to use CBT as a probe to study the relationship between specific disease-related alterations of the brain, the gut microbiome, and symptomatic outcome, and identify the role of sex differences in these relationships. Investigators will study male and female IBS patients before and after CBT using the advanced neuroimaging and microbiome technologies of the overall SCOR.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05155631
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for IBS - Irritable Bowel Syndrome
Currently open trials in the same condition.
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- NCT06117865 — Digital Treatment of Irritable Bowel Syndrome (IBS) · NA · active not recruiting
- NCT06215222 — Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease · recruiting
- NCT05815602 — Ebastine Versus Mebeverine in IBS Patients · Phase 3 · recruiting
Other University of California, Los Angeles trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05155631 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, Los Angeles
- Last refreshed: 16 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05155631.
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