Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 92 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05155631
The ClinicalTrials.gov registry entry for NCT05155631 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which COGNITIVE BEHAVIORAL THERAPY is the first listed.
NCT05155631 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.