Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
728 participants
INTERVENTIONAL
2023-12-01
2033-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Patient education
Module 1
Module 1: Introduction to IBS by a gastroenterologist.
Module 2
Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.
Module 3
Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
Behavioral therapy
Module 1
Module 1: Introduction to IBS by a gastroenterologist.
Module 2
Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.
Module 3
Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
Module 4
Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).
Low FODMAP-diet
Module 1
Module 1: Introduction to IBS by a gastroenterologist.
Module 2
Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.
Module 3
Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
Module 5
Module 5: Intervention: The low FODMAP diet.
Combined treatment
Low FODMAP-diet and behavioral therapy
Module 1
Module 1: Introduction to IBS by a gastroenterologist.
Module 2
Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.
Module 3
Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
Module 4
Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).
Module 5
Module 5: Intervention: The low FODMAP diet.
Interventions
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Module 1
Module 1: Introduction to IBS by a gastroenterologist.
Module 2
Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.
Module 3
Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
Module 4
Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).
Module 5
Module 5: Intervention: The low FODMAP diet.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Locations
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Haukeland University Hospital
Bergen, Vestlandet, Norway
Countries
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Other Identifiers
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2023-630038
Identifier Type: -
Identifier Source: org_study_id
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