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Digital Treatment of Irritable Bowel Syndrome (IBS)

NCT06117865 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 728

Last updated 2025-05-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Haukeland University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-02-28
Completion
2033-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06117865 on ClinicalTrials.gov