Personalised Multidisciplinary Treatment in Moderate to Severe IBS

NCT07534930 | Active Not Recruiting

• 1 other identifier: DNR201902932
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• IBS symptom severity score

  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.

  From enrollment through 1 year after completion of multimodal, multidisciplinary treatment.

Secondary Outcomes (8)

• Changes in Gastrointestinal symptom severity

  Baseline, 3, 6, 9, and 12 months

• Psychological symptom burden

  At the baseline, 3 months, 6 months, 9 months and end of intervention (12 months)

• Visceral sensitivity index (VSI)

  Baseline, 3, 6, 9, and 12 months

• Changes in Gut-brain axis physiology

  Baseline and 12 months.

• Brain imaging outcomes - Brain Structure

  At the baseline and after 12 months.

Study Arms (1)

Multidisciplinary multimodal intervention (IBS)

ACTIVE COMPARATOR

Single-arm intervention: all participants are assigned to a multimodal, multidisciplinary IBS treatment program delivered by a multidisciplinary team. No control group was included due to the nature of the study.

Other: Physician-module; Other: Dietician module; Other: Psychologist module; Other: Physiotherapy module

Interventions

Physician-module OTHER

Individualized medical management by a gastroenterologist targeting predominant IBS symptoms (pain, diarrhea/constipation, bloating) with evidence-based pharmacological and bowel-regulation strategies as needed.

Multidisciplinary multimodal intervention (IBS)

Dietician module OTHER

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

Multidisciplinary multimodal intervention (IBS)

Psychologist module OTHER

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.

Multidisciplinary multimodal intervention (IBS)

Physiotherapy module OTHER

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.

Multidisciplinary multimodal intervention (IBS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead
• Ostergotland County Council, Sweden: collaborator
• The Kamprad Family Foundation for Entrepreneurship, Research & Charity: collaborator

Study Sites (1)

Linköping University Hospital

Linköping, Linköping, 58185, Sweden

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD and Adjunct Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 16, 2026
• Study Start: September 23, 2021
• Primary Completion: April 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)