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

Last updated: July 7, 2025
Sponsor: University of Melbourne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Irritable Bowel Syndrome (Ibs)

Gastrointestinal Diseases And Disorders

Colic

Treatment

FODMAP Diet

Exposure-based Cognitive Behavioral Therapy

Clinical Study ID

NCT06940596
CT31293
2024
APP2025943
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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, orGastroenterologist, 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 onlinetreatment

  • Willing to make dietary or behavioral changes in line with the allocated treatmentprogram

  • Ability to provide informed consent

Exclusion

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, InflammatoryBowel Disease) or history of gastrointestinal cancer

  • History of major gastrointestinal surgery (not appendectomy, cholecystectomy orhemorrhoidectomy)

  • Individuals who report alarm symptoms (e.g., blood in stool, recentunexplained/unintentional weight loss >5% body weight, a recent change in bowelhabits if >50 years, family history of gastrointestinal cancer or gastrointestinaldiseases, large volumes of diarrhea occurring at night, fever associated with gutsymptoms, recurrent vomiting, persistent unexplained iron deficiency) will beexcluded if appropriate medical investigations have not been conducted, unlesswritten medical approval is provided from a general practitioner, family physical,or gastroenterologist.

  • Diagnosis of major disease that could explain current gastrointestinal symptoms suchas 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 activesuicidal 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 interventionperiod

  • Commenced or change in dose of antibiotics and medications that potentially affectthe gastrointestinal transit (e.g. anti-diarrheals and laxatives) in the 3 monthspreceding study commencement.

  • Commenced taking or changed dose of probiotics, prebiotics, fibre supplements anddigestive enzymes in the 3 months preceding study commencement

  • Commenced or change dose in psychotropic medication in the 3 months preceding studycommencement

  • Are currently undertaking behavioral therapy for IBS (including cognitive behavioraltherapy, CBT), or have undertaken clinician-delivered behavioral therapy for thetreatment of IBS

  • Are currently undertaking or have undertaken a dietitian-prescribed and deliveredrestrictive diet for IBS (e.g., FODMAP diet).

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: FODMAP Diet
Phase:
Study Start date:
May 22, 2025
Estimated Completion Date:
July 31, 2027

Study Description

This research uses a randomized controlled trial to investigate the treatment of irritable bowel syndrome (IBS). A range of treatments for IBS are available, but each work for only a portion of patients, and it is unclear why. This research project will assess how two treatments (one dietary and one behavioral) work and for whom. Investigators will do this by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works). This project 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. This treatment involves 3-phases: FODMAP restriction (phase 1), FODMAP re-introduction (phase 2), and FODMAP personalization (phase 3), or, ii. An Exposure-based Cognitive Behavioral Therapy (E-CBT) online program for IBS that focuses on symptom-related behaviors such as avoidance of activities and foods, excessive toilet visits, and behaviors to control symptoms which are known to worsen IBS symptoms. E-CBT uses daily self-observation and exposure exercises to change these behaviors to relieve IBS symptoms. Investigators believe that both treatments, FODMAP diet and E-CBT, will lead to an improvement in IBS gastrointestinal symptoms. Primary moderators and mediators to be assessed include gastrointestinal symptom anxiety, food avoidance behaviour and FODMAP intake.

Connect with a study center

  • University of Melbourne

    Melbourne, Victoria 3010
    Australia

    Active - Recruiting

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