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Behavioral Intervention

Cognitive Behavioral Therapy for Irritable Bowel Syndrome (U54_P3_CBT Trial)

N/A

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 55 years of age, inclusive

Must be absent of red flags including unexplained weight loss, fevers, anemia or blood in stools

Must not have

Use of antibiotics or probiotics within 3 months of the study enrollment or regular use of probiotics within 4 weeks of enrollment

Malignancy (other than localized skin cancer that has been resected) within the previous 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will use CBT to study the relationship between the brain, the gut microbiome, and symptomatic outcome in IBS patients, with the goal of identifying the role of sex differences in these relationships.

Who is the study for?

This trial is for men and women aged 18-55 with IBS, meeting ROME IV criteria. Women must be premenopausal, not pregnant or breastfeeding, and willing to use non-hormonal birth control. Participants should have no major psychiatric diagnoses or significant medical conditions that could interfere with the study.

What is being tested?

The effectiveness of Cognitive Behavioral Therapy (CBT) on IBS is being tested, focusing on sex differences in response. The study involves advanced neuroimaging and microbiome analysis before and after CBT to understand brain-gut-microbiome interactions.

What are the potential side effects?

Since CBT is a type of psychotherapy involving talking and behavior modification strategies without medication, it typically does not cause physical side effects but may sometimes lead to temporary increases in distress as difficult topics are discussed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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I don't have unexplained weight loss, fevers, anemia, or blood in my stools.

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I can walk without relying solely on a wheelchair.

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I am a woman who has not gone through menopause and still gets periods.

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I can speak English fluently.

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I have been diagnosed with or show symptoms of Irritable Bowel Syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken antibiotics or probiotics within 3 months before joining the study.

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I haven't had cancer, except for treated skin cancer, in the last 5 years.

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I regularly use narcotics or opioids.

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I have had chronic pain for more than 6 months, not related to IBS.

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My IBS is at least moderately severe according to the IB-SSS.

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My BMI is over 35.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Abundance of Clostridiales taxa

Irritable Bowel Symptom Severity scale (IBSSS)

KYN/TR ratio.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Behavioral Treatment ArmExperimental Treatment1 Intervention

Subjects in the "Cognitive Behavioral Treatment" Arm will undergo 8-10 weeks of remote cognitive behavioral therapy. Subjects will complete modules on their phones and will be monitored by study coordinators for support and treatment completion.

Group II: Usual Care ArmActive Control1 Intervention

Subjects in the "Usual Care" Arm will undergo 8-10 weeks of continued lifestyle. Subjects will be asked to report any new medications or lifestyle changes to study coordinators throughout the 8-10 weeks.

0 / 12Eligibility criteria met