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NCT05155631 · ClinicalTrials.gov registry record · NA
Sex Differences in Effectiveness of CBT on IBS Project 3
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 92
- Enrollment target
NCT05155631: Completed NA study, sponsored by University of California, Los Angeles.
NCT05155631 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 92 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05155631, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Degree of connectivity between pre-drawn areas of the brainstem containing pontine nuclei and regions of the salience, emotional arousal, and sensorimotor brain networks will be quantified during a resting state functional MRI scan. The number of significant connections will be determined for pre and post treatment scans for the CBT and usual care conditions and the changes in connectivity following treatment compared for the two conditions.
Interventions
- BEHAVIORAL COGNITIVE BEHAVIORAL THERAPY
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2021-12-18 |
| Est. Completion | 2025-01-01 |
| Phase | NA |
What the finished NCT05155631 record still lists
NCT05155631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which COGNITIVE BEHAVIORAL THERAPY is the first listed.
NCT05155631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05155631 about?
NCT05155631 is a clinical study titled "Sex Differences in Effectiveness of CBT on IBS Project 3". 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...
What is the current status of trial NCT05155631?
This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2021-12-18. Estimated completion is 2025-01-01.
What interventions are being tested in trial NCT05155631?
The interventions under investigation include: COGNITIVE BEHAVIORAL THERAPY (BEHAVIORAL).
Who is sponsoring clinical trial NCT05155631?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05155631's enrollment target sits among peer trials
92 937th of 2000 higher than 1,062 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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