Clinical Research Directory
Browse clinical research sites, groups, and studies.
Digital Treatment of Irritable Bowel Syndrome (IBS)
Sponsor: Haukeland University Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
728
Start Date
2023-12-01
Completion Date
2033-12-31
Last Updated
2025-05-16
Healthy Volunteers
No
Conditions
Interventions
Module 1
Module 1: Introduction to IBS by a gastroenterologist.
Module 2
Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.
Module 3
Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
Module 4
Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).
Module 5
Module 5: Intervention: The low FODMAP diet.
Locations (1)
Haukeland University Hospital
Bergen, Vestlandet, Norway