Digital Treatment of Irritabel Bowel Syndrome (IBS)

Study Overview
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Brief Summary
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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 treamtent 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 registred 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 defines as an improvement of 50 points or more on the IBS severity scoring system at 3 months agter treatment start compared to the score beofre treatment.

Official Title
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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

Conditions
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IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Module 1
* Behavioral: Module 2
* Behavioral: Module 3
* Behavioral: Module 4
* Behavioral: Module 5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Diagnosed with IBS in the primary or secondary healthcare service. Patients aged 18-70 years with IBS defined by the Rome IV criteria: Recurrent abdominal pain, on average at least 1 day per week during the previous 3 months, that is associated with two or more of the following: i) Defecation, either increased pain or pain relief, ii) Change in stool frequency, iii) Change in stool form (appearance) All participants >50 years: Colonoscopy within the last 5 years prior to study entry excluding other pathology Bank-ID and access to tablet, PC or smart phone. No known presence of: symptomatic endometriosis, Diabetes type 1 and 2, Malignant disease (excluding basalioma), No history of: severe psychiatric disorder, alcohol or drug abuse, inflammatory bowel disease, microscopic colitis, diverticulitis or ileus, major abdominal surgery (except appendectomy, cholecystectomy, caesarean section, and hysterectomy) No red flags'' indicating severe undiagnosed disease: Night sweats (Repeated episodes of extreme perspiration that may soak nightclothes or bedding), Unintentional weight loss (≥ 4.5 kilograms, or 5% of normal body weight) over less than 6 months without knowing the reason, or blood in stool Not pregnant Ability to comply with protocol requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Patient education<br> | Behavioral: Module 1<br>* Module 1: Introduction to IBS by a gastroenterologist.<br>Behavioral: Module 2<br>* Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.<br>Behavioral: Module 3<br>* Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.<br>|
| Active Comparator: Behavioral therapy<br> | Behavioral: Module 1<br>* Module 1: Introduction to IBS by a gastroenterologist.<br>Behavioral: Module 2<br>* Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.<br>Behavioral: Module 3<br>* Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.<br>Behavioral: Module 4<br>* Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).<br>|
| Active Comparator: Low FODMAP-diet<br> | Behavioral: Module 1<br>* Module 1: Introduction to IBS by a gastroenterologist.<br>Behavioral: Module 2<br>* Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.<br>Behavioral: Module 3<br>* Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.<br>Behavioral: Module 5<br>* Module 5: Intervention: The low FODMAP diet.<br>|
| Active Comparator: Combined treatment<br>Low FODMAP-diet and behavioral therapy | Behavioral: Module 1<br>* Module 1: Introduction to IBS by a gastroenterologist.<br>Behavioral: Module 2<br>* Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.<br>Behavioral: Module 3<br>* Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.<br>Behavioral: Module 4<br>* Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).<br>Behavioral: Module 5<br>* Module 5: Intervention: The low FODMAP diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBD-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. | 3 months after treatment start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital treatment