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Recruiting NCT06940596

Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?

Trial Parameters

Condition Irritable Bowel Syndrome (IBS)
Sponsor University of Melbourne
Study Type INTERVENTIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-05-22
Completion 2027-01
Interventions
FODMAP DietExposure-based Cognitive Behavioral Therapy

Brief Summary

This research project will assess how two treatments for irritable bowel syndrome (one dietary and one behavioral) work and for whom. This will be done by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works). Investigators will also assess how the diet and behavioral treatments affect IBS symptoms during treatment. Participants will be randomized to either: i. A FODMAP diet online program that focuses on modifying the consumption of foods high or moderate in fermentable carbohydrates (FODMAPS) to manage IBS symptoms. or, ii. An Exposure-based Cognitive Behavioral Therapy (E-CBT) online program for IBS that focuses on changing symptom-related behaviors which are known to worsen IBS symptoms.

Eligibility Criteria

Inclusion Criteria: Each participant must meet all of the following criteria to be enrolled in this trial: * Living in Australia or the United States * Aged 18 years or older * Body Mass Index (BMI) \[Equation\]18.5kg/m2 and \[Equation\] 34.9kg/m2 * Diagnosed with IBS by a General Practitioner, Family Physician, or Gastroenterologist, or Advanced Specialist Dietitian * Currently fulfill Rome IV criteria for IBS * Symptomatic at the time of recruitment (IBS-SSS \> 175) * Access to a computer and internet * Sufficient English language and computer skills to complete a text-based online treatment * Willing to make dietary or behavioral changes in line with the allocated treatment program * Ability to provide informed consent Exclusion Criteria:Patients meeting any of the following criteria will be excluded from the trial: * Presence or known history of other GI disease (e.g. coeliac disease, Inflammatory Bowel Disease) or history of gastrointestinal cancer * History of major gastrointesti

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