Personalised Multidisciplinary Treatment in Moderate to Severe IBS
NCT07534930 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-04-16
Summary
This is a 12-month longitudinal intervention study in adults (18-65 years) with moderate-severe IBS (IBS-SSS ≥175) evaluating a personalized, patient-centered multidisciplinary treatment delivered in a Swedish tertiary care setting. The program includes an internet-based IBS school followed by four evidence-based modules (physician-led medical management/education, dietician-led dietary intervention, psychologist-led IBS-focused behavioral therapy, and physiotherapy) delivered in a sequence chosen by the participant, with symptom evaluation after each module. Outcomes are assessed before and after treatment, with the primary endpoint defined as treatment response (IBS-SSS reduction ≥50 points), and secondary endpoints covering symptom/psychological measures, visceral sensitivity and biological stress plus gut biomarkers, and multimodal brain imaging (structural MRI, rs-fMRI, task fMRI, and insula MRS).
Conditions
- IBS (Irritable Bowel Syndrome)
- DGBI
Interventions
- OTHER
-
Physician-module
Individualized medical management by a gastroenterologist targeting predominant IBS symptoms (pain, diarrhea/constipation, bloating) with evidence-based pharmacological and bowel-regulation strategies as needed.
- OTHER
-
Dietician module
Individualized dietician guided treatment with either lowFODMAP diet or traditional IBS dietary advice.
- OTHER
-
Psychologist module
Evidence-based psychological treatment for IBS (e.g., CBT/IBS-focused behavioral therapy) targeting symptom-related anxiety, stress, coping strategies, and gut-brain symptom amplification.
- OTHER
-
Physiotherapy module
Targeted physiotherapy addressing pain modulation and bodily stress responses, including education and individualized exercises/relaxation strategies to improve symptom management and functional capacity. In case of fecal incontinence and pelvic floor dysynergia biofeedback was administrated.
Sponsors & Collaborators
-
Ostergotland County Council, Sweden
collaborator OTHER -
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
collaborator OTHER -
Linkoeping University
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-23
- Primary Completion
- 2026-04-15
- Completion
- 2026-06-15
Countries
- Sweden
Study Locations
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