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ACTIVE NOT RECRUITING
NCT07534930
NA

Personalised Multidisciplinary Treatment in Moderate to Severe IBS

Sponsor: Linkoeping University

View on ClinicalTrials.gov

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).

Official title: Personalised Multidisciplinary Multimodal Treatment in IBS

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-09-23

Completion Date

2026-06-15

Last Updated

2026-04-16

Healthy Volunteers

No

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.

Locations (1)

Linköping University Hospital

Linköping, Linköping, Sweden