NCT07534930

Personalised Multidisciplinary Treatment in Moderate to Severe IBS

Personalised Multidisciplinary Multimodal Treatment in IBS

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Linkoeping University · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-09-23
• Primary completion: 2026-04-15
• Completion: 2026-06-15
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Sweden