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

Launched by UNIVERSITY OF MELBOURNE · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how two different treatments can help people with Irritable Bowel Syndrome (IBS), a condition that affects the digestive system and can cause symptoms like stomach pain and bloating. The study will compare an online program that teaches participants to follow a special diet low in certain carbohydrates (called the FODMAP diet) with another online program that uses cognitive behavioral therapy (E-CBT) to change behaviors that may worsen IBS symptoms. Researchers want to find out which treatment works better for different people and how these treatments help improve IBS symptoms.

To be eligible for this trial, participants need to be at least 18 years old, live in Australia or the United States, and have been diagnosed with IBS. They should also be experiencing symptoms and have access to a computer and the internet. It's important to note that individuals with certain other health issues, such as other gastrointestinal diseases or serious mental health conditions, will not be able to participate. Those who join the study can expect to engage in either the diet program or the behavioral therapy program for 12 weeks, and they will help researchers understand how effective these treatments are for managing IBS symptoms.

Gender

ALL

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 gastrointestinal surgery (not appendectomy, cholecystectomy or hemorrhoidectomy)
• • Individuals who report alarm symptoms (e.g., blood in stool, recent unexplained/unintentional weight loss \>5% body weight, a recent change in bowel habits if \>50 years, family history of gastrointestinal cancer or gastrointestinal diseases, large volumes of diarrhea occurring at night, fever associated with gut symptoms, recurrent vomiting, persistent unexplained iron deficiency) will be excluded if appropriate medical investigations have not been conducted, unless written medical approval is provided from a general practitioner, family physical, or gastroenterologist.
• • Diagnosis of major disease that could explain current gastrointestinal symptoms such as severe diabetic, cardiac, liver, neurological, neuropathy disease
• • History or current diagnosis of psychotic disorder or bipolar disorder
• • Current diagnosis of substance abuse disorder or major depressive disorder or active suicidal ideation
• • History or current diagnosis of an eating disorder
• • Current enteral/parenteral feeding or use of supplemental feeds (e.g. Ensure)
• • Pregnant or lactating or planning to become pregnant during the 12-week intervention period
• • Commenced or change in dose of antibiotics and medications that potentially affect the gastrointestinal transit (e.g. anti-diarrheals and laxatives) in the 3 months preceding study commencement.
• • Commenced taking or changed dose of probiotics, prebiotics, fibre supplements and digestive enzymes in the 3 months preceding study commencement
• • Commenced or change dose in psychotropic medication in the 3 months preceding study commencement
• • Are currently undertaking behavioral therapy for IBS (including cognitive behavioral therapy, CBT), or have undertaken clinician-delivered behavioral therapy for the treatment of IBS
• • Are currently undertaking or have undertaken a dietitian-prescribed and delivered restrictive diet for IBS (e.g., FODMAP diet).