Personalised Multidisciplinary Treatment in Moderate to Severe IBS

NCT07534930 · tracked via the Priya Life Science Sweden tracker

Sponsor

Linkoeping University

Phase

Not applicable

Started

2021-09-23

Last updated

2026-04-16

Condition(s) studied

IBS (Irritable Bowel Syndrome)DGBI

Investigational drug(s) / intervention(s)

Physician-moduleDietician modulePsychologist modulePhysiotherapy module

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.

Dietician module: Individualized dietician guided treatment with either lowFODMAP diet or traditional IBS dietary advice.

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.

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * IBS diagnosis confirmed according to the Rome IV criteria * Moderate-to-severe symptoms based on the IBS Symptom Severity Score (IBS-SSS) * Age 18-65 years * Written informed consent. Exclusion Criteria: * Contraindications to MRI, e.g., claustrophobia, pregnancy, or metallic implants. * History of major gastrointestinal surgery, e.g., appendectomy. * Severe psychiatric illness, such as bipolar disorder or schizophrenia. * Insufficient Swedish language knowledge to complete the questionnaires

Primary outcome measure(s)

IBS symptom severity score — From enrollment through 1 year after completion of multimodal, multidisciplinary treatment.
The primary outcome was treatment response, defined as a reduction of ≥50 points in the IBS Symptom Severity Score (IBS-SSS). Participants achieving this reduction were classified as responders.

Trial sites (1)

Facility	City	Region	Status
Linköping University Hospital	Linköping	Linköping