Status:
ACTIVE_NOT_RECRUITING
Digital Treatment of Irritable Bowel Syndrome (IBS)
Lead Sponsor:
Haukeland University Hospital
Conditions:
IBS - Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 treatmt...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
728 Patients enrolled
Trial Details
Trial ID
NCT06117865
Start Date
December 1 2023
End Date
December 31 2033
Last Update
May 16 2025
Active Locations (1)
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1
Haukeland University Hospital
Bergen, Vestlandet, Norway, 5021