Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom, and How? A Randomized Controlled Trial of Internet-Delivered FODMAP Diet Versus Exposure-Based Cognitive Behavioral Therapy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
University of Melbourne
RECRUITING
Melbourne
Contact Information
Primary
Jessica Biesiekierski, A/Prof
jessica.biesiekierski@unimelb.edu.au
+61 499 272 673
Backup
Jacqueline L Anderson, APD
jacquia@student.unimelb.edu.au
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2027-07
Participants
Target number of participants: 200
Treatments
Experimental: FODMAP Diet
Fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) Diet is a 12-week online intervention with dietitian support.
Experimental: Exposure-based Cognitive Behavioral Therapy (E-CBT)
Exposure-based Cognitive Behavioral Therapy is a 12-week online intervention with psychologist support.
Related Therapeutic Areas
Sponsors
Collaborators: Monash University
Leads: University of Melbourne

This content was sourced from clinicaltrials.gov