Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Melbourne
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- FODMAP Diet
- Exposure-based Cognitive Behavioral Therapy
Treatment groups
235 Participants
are divided into 2 treatment groupsLocations
1University of Melbourne3010, MelbourneVictoria, Australia
Sponsors and collaborators
University of Melbourne
Lead sponsor
Monash University
Collaborator
Source ClinicalTrials.gov