Actively Recruiting
Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?
Led by University of Melbourne · Updated on 2026-05-06
235
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
Sponsors
U
University of Melbourne
Lead Sponsor
M
Monash University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Living in Australia or the United States
- Aged 18 years or older
- Body Mass Index (BMI) between 18.5 kg/m2 and 34.9 kg/m2
- Diagnosed with IBS by a General Practitioner, Family Physician, Gastroenterologist, or Advanced Specialist Dietitian
- Currently meet Rome IV criteria for IBS
- Symptomatic at 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 according to the assigned treatment
- Able to provide informed consent
You will not qualify if you...
- Presence or history of other gastrointestinal diseases such as coeliac disease, Inflammatory Bowel Disease, or gastrointestinal cancer
- History of major gastrointestinal surgery (except appendectomy, cholecystectomy, or hemorrhoidectomy)
- Reporting alarm symptoms without appropriate medical investigation or approval (e.g., blood in stool, recent unexplained weight loss >5%, recent change in bowel habits if over 50, family history of gastrointestinal cancer or diseases, large volumes of diarrhea at night, fever with gut symptoms, recurrent vomiting, persistent unexplained iron deficiency)
- Diagnosis of major diseases explaining gastrointestinal symptoms (e.g., severe diabetes, cardiac, liver, neurological, neuropathy diseases)
- History or current diagnosis of psychotic or bipolar disorder
- Current diagnosis of substance abuse, major depressive disorder, or active suicidal thoughts
- History or current diagnosis of an eating disorder
- Current enteral or parenteral feeding or use of supplemental feeds
- Pregnant, lactating, or planning pregnancy during the 12-week intervention
- Recent (within 3 months) start or dose change of antibiotics or medications affecting gastrointestinal transit
- Recent (within 3 months) start or dose change of probiotics, prebiotics, fiber supplements, or digestive enzymes
- Recent (within 3 months) start or dose change of psychotropic medication
- Currently undergoing or previously undergone behavioral therapy for IBS
- Currently undergoing or previously undergone a dietitian-prescribed restrictive diet for IBS such as the FODMAP diet
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Melbourne
Melbourne, Victoria, Australia, 3010
Actively Recruiting
Research Team
J
Jessica Biesiekierski, A/Prof
CONTACT
J
Jacqueline L Anderson, APD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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