Digital Treatment of Irritable Bowel Syndrome (IBS)
Key facts
- Who runs it
- Haukeland University Hospital
- Where
- Norway1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 728 people, planned
- Started
- 1 Dec 2023
- Expected to end
- 31 Dec 2033
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Module 1
- Module 2
- Module 3
- Module 4
- Module 5
- Record updated
- 16 May 2025
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Patient educationSham treatment, for comparison
Treatment: Module 1, Module 2, and Module 3
- Behavioral therapyExisting treatment, for comparison
Treatment: Module 1, Module 2, Module 3, and Module 4
- Low FODMAP-dietExisting treatment, for comparison
Treatment: Module 1, Module 2, Module 3, and Module 5
- Combined treatmentExisting treatment, for comparison
Low FODMAP-diet and behavioral therapy
Treatment: Module 1, Module 2, Module 3, Module 4, and Module 5
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Publications
- Record updated
- 16 May 2025