NCT06117865

Digital Treatment of Irritable Bowel Syndrome (IBS)

A Randomized Controlled Digital Intervention Study to Assess the Effect of Internet Delivered Interventions, the Low FODMAP-diet, Behavioral Therapy or Both, Compared to Patient Education, on Measures of Gastrointestinal Symptom Relief and Quality of Life in Patients With Irritable Bowel Syndrome

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 728 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this work is to identify whether the digital treatment program Mage-tarmskolen has an effect on patients with IBS. Our secondary objectives is to address multiple aspects of digital treatmtent success of the different modules. The patients will be randomized to one of four arms and will be delivered different kinds of digital treatment. All patients will have access to ask questions to a registered dietitian. Primary end point is the proportion of patients with treatment success in the low FODMAP, behavioral therapy or both groups, versus the patient education group (sham). Treatment effect is defined as an improvement of 50 points or more on the IBS severity scoring system at 3 months after treatment start compared to the score before treatment.

Conditions

• IBS - Irritable Bowel Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Module 1	Module 1: Introduction to IBS by a gastroenterologist.
BEHAVIORAL	Module 2	Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.
BEHAVIORAL	Module 3	Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
BEHAVIORAL	Module 4	Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).
BEHAVIORAL	Module 5	Module 5: Intervention: The low FODMAP diet.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-02-28
• Completion: 2033-12-31
• First posted: 2023-11-07
• Last updated: 2025-05-16

Locations

1 site across 1 country: Norway