Review article: exclude or expose? The paradox of conceptually opposite treatments for irritable bowel syndrome.
Jessica R Biesiekierski, Lauren P Manning, Helen Burton Murray...
https://pubmed.ncbi.nlm.nih.gov/35775328Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06940596
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
Led by University of Melbourne · Updated on 2026-05-06
235
Participants Needed
1
Research Sites
26 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
Researchers are studying how two different treatments work for people with irritable bowel syndrome (IBS) and for whom they are most effective. The study aims to understand both the factors that influence which treatment works best for each person and the ways these treatments affect IBS symptoms. This is a randomized controlled trial comparing an online dietary program and an online behavioral therapy program for IBS. Participants will be randomly assigned to one of two 12-week online programs. One group will follow the FODMAP diet program, which involves three phases: restricting foods high in certain fermentable carbohydrates, reintroducing foods to test tolerance, and personalizing the diet to maintain symptom relief. This program includes support from a dietitian. The other group will participate in Exposure-based Cognitive Behavioral Therapy (E-CBT), a six-step behavioral program focusing on changing symptom-related behaviors through self-observation and exposure exercises, with support from a psychologist. During the study, participants will complete weekly assessments of their gastrointestinal symptoms, as well as questionnaires on symptom severity, quality of life, anxiety, food avoidance, and other related measures at baseline, after the 12-week intervention, and at 3- and 6-month follow-ups. Additional data, including stool samples and food diaries, will be collected to understand biological and behavioral changes. Researchers will monitor how symptoms improve and explore what factors affect treatment success, with total participation lasting at least six months after the intervention.
CONDITIONS
Brief Title
Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?
Who Can Participate
Age: 18Years +
All Genders
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 irritable bowel syndrome (IBS) by a General Practitioner, Family Physician, Gastroenterologist, or Advanced Specialist Dietitian
- Currently meet Rome IV criteria for IBS
- Symptomatic at recruitment with IBS Symptom Severity Score (IBS-SSS) greater than 175
- Have access to a computer and internet
- Have sufficient English language and computer skills to complete an 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)
- Individuals with alarm symptoms without appropriate medical investigations or without medical approval
- Diagnosis of major diseases that could explain gastrointestinal symptoms like severe diabetes, cardiac, liver, neurological, or neuropathy disorders
- History or current diagnosis of psychotic disorder, bipolar disorder, substance abuse disorder, major depressive disorder, or active suicidal ideation
- History or current diagnosis of an eating disorder
- Current use of enteral or parenteral feeding or supplemental feeds
- Pregnant, lactating, or planning pregnancy during the 12-week intervention
- Recent changes in antibiotics, medications affecting gut transit, probiotics, prebiotics, fiber supplements, digestive enzymes, or psychotropic medication within 3 months before the study
- Currently undergoing or have undergone behavioral therapy for IBS or restrictive diet prescribed by a dietitian for IBS (including FODMAP diet) before the study
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or online)
Treatment
Duration - 12 weeks
Participants receive one of two 12-week online treatments for IBS: a FODMAP diet program with dietitian support or an Exposure-based Cognitive Behavioral Therapy program with psychologist support. Each treatment involves weekly modules with homework activities and clinician feedback.
Weekly online sessions with clinician feedback
Follow-up
Duration - 6 months
Participants are monitored to assess changes in IBS symptoms and quality of life at 3 and 6 months after completing the treatment.
2 follow-up assessments at 3 and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
University of Melbourne
Melbourne, Victoria, Australia, 3010
Actively Recruiting
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Research Team
J
Jessica Biesiekierski, A/Prof
J
Jacqueline L Anderson, APD
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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