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Sex Differences in Effectiveness of CBT on IBS Project 3 - Trial NCT05155631

Access comprehensive clinical trial information for NCT05155631 through Pure Global AI's free database. This phase not specified trial is sponsored by University of California, Los Angeles and is currently Recruiting. The study focuses on IBS - Irritable Bowel Syndrome. Target enrollment is 150 participants.

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NCT05155631
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behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT05155631
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Sex Differences in Effectiveness of CBT on IBS Project 3
Sex Related Differences in the Effect of Cognitive Behavioral Therapy (CBT) on Emotional Arousal and Salience Circuits and the Role of the Gut Microbiome

Study Focus

COGNITIVE BEHAVIORAL THERAPY

Interventional

behavioral

Sponsor & Location

University of California, Los Angeles

Los Angeles, United States of America

Timeline & Enrollment

N/A

Dec 18, 2021

Apr 01, 2025

150 participants

Primary Outcome

Degree of connectivity between brainstem nuclei and the salience, emotional arousal and sensorimotor networks brain networks.

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.

ICD-10 Classifications

Irritable bowel syndrome with predominant constipation [IBS-C]
Irritable bowel syndrome
Irritable bowel syndrome with predominant diarrhoea [IBS-D]
Irritable bowel syndrome with mixed bowel habits [IBS-M]
Other and unspecified irritable bowel syndrome

Data Source

ClinicalTrials.gov

NCT05155631

Non-Device Trial