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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient education | Sham Comparator |
| |
| Behavioral therapy | Active Comparator |
| |
| Low FODMAP-diet | Active Comparator |
| |
| Combined treatment | Active Comparator | Low FODMAP-diet and behavioral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Module 1 | Behavioral | Module 1: Introduction to IBS by a gastroenterologist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| IBS-SSS | Treatment success is defined as an improvement of ≥50 points on the IBS severity scoring system (IBS-SSS) at 3 months after treatment start, compared to the score before treatment | 3 months after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| IBS-QOL | ≥10-point increase in the IBS-Qualiy of Life (IBS-QoL) at 3 months compared to the score before treatment. | 3 months after treatment start |
| HADS | ≥3-point decrease in HADS at 3 months compared to the score before treatment. |
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Inclusion Criteria:
- Diagnosed with IBS in the primary or secondary healthcare service.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Vestlandet | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42094852 | Derived | Thuen C, Kenter RMF, Assmus J, Steinsvik EK, Vikoren LAS, Lied GA, Berentsen B. Internet-delivered cognitive behavioral therapy and FODMAP diet for adults with irritable bowel syndrome: A four-arm randomized controlled trial. Internet Interv. 2026 Apr 26;44:100949. doi: 10.1016/j.invent.2026.100949. eCollection 2026 Jun. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Module 2 | Behavioral | Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises. |
|
| Module 3 | Behavioral | Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian. |
|
| Module 4 | Behavioral | Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy). |
|
| Module 5 | Behavioral | Module 5: Intervention: The low FODMAP diet. |
|
| 3 months after treatment start |
| D004066 | Digestive System Diseases |