NCT06117865: DIGIBS

Digital Treatment of Irritable Bowel Syndrome (IBS)

Active, enrolled NA Last updated 16 May 2025

What this trial tests

NA trial testing Module 1 in IBS - Irritable Bowel Syndrome in 728 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 December 2023

Primary endpoint
28 February 2025

31 December 2033

Quick facts

Lead sponsor	Haukeland University Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	728
Start date	1 December 2023
Primary completion	28 February 2025
Estimated completion	31 December 2033
Sites	1 location across Norway

Drugs / interventions tested

• Module 1
• Module 2
• Module 3
• Module 4
• Module 5

Conditions studied

• IBS - Irritable Bowel Syndrome — all drugs for IBS - Irritable Bowel Syndrome →

Sponsor

Haukeland University Hospital

Who can join

Adults 18 to 70, any sex, with IBS - Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Internet-delivered cognitive behavioral therapy and FODMAP diet for adults with irritable bowel syndrome: A four-arm randomized controlled trial.
   Thuen C, Kenter RMF, Assmus J, Steinsvik EK, et al · · 2026 · PMID 42094852 · DOI 10.1016/j.invent.2026.100949
2. Predictors of response to a multidisciplinary internet-delivered intervention for irritable bowel syndrome: An explorative secondary analysis of a randomized controlled trial
   Thuen C, Dear B, Kenter RMF, Steinsvik EK, et al · · 2026 · DOI 10.21203/rs.3.rs-9503908/v1