Personalised Multidisciplinary Treatment in Moderate to Severe IBS

NCT07534930 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-16

No results posted yet for this 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).

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07534930 on ClinicalTrials.gov