Personalised Multidisciplinary Treatment in Moderate to Severe IBS (Magont)

Personalised Multidisciplinary Multimodal Treatment in IBS

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).

Study Overview

• Status: Active, not recruiting
• Conditions: IBS (Irritable Bowel Syndrome); DGBI
• Intervention / Treatment: Other: Physician-module; Other: Dietician module; Other: Psychologist module; Other: Physiotherapy module

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping
    • Linköping, Linköping, Sweden, 58185
      • Linköping University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Multidisciplinary multimodal intervention (IBS); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gastrointestinal symptom severity	Change from baseline in gastrointestinal symptom severity measured using the Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS), with higher scores indicating more severe gastrointestinal symptoms).	Baseline, 3, 6, 9, and 12 months
Psychological symptom burden	Change from baseline in anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS). The scale consists of two subscales (anxiety and depression), each ranging from 0 to 21, with higher scores indicating greater symptom severity.	At the baseline, 3 months, 6 months, 9 months and end of intervention (12 months)
Visceral sensitivity index (VSI)	Change from baseline in visceral anxiety measured by the Visceral Sensitivity Index (VSI). The total score ranges from 0 to 75, with higher scores indicating greater gastrointestinal-specific anxiety.	Baseline, 3, 6, 9, and 12 months
Changes in Gut-brain axis physiology	Change from baseline in rectal sensory thresholds measured using rectal barostat testing. Thresholds will be expressed as pressure and/or volume at first sensation, urge, and maximum tolerable distension. Change from baseline in intestinal permeability measured using Ussing chamber assessment of mucosal permeability. Results will be expressed according to the laboratory-specific permeability measure used.	Baseline and 12 months.
Brain imaging outcomes - Brain Structure	Change from baseline in regional gray matter volume measured using structural magnetic resonance imaging (MRI).	At the baseline and after 12 months.
Brain imaging outcomes - Brain neurochemistry	Change from baseline in brain metabolite, in insula, such as GABA concentrations measured using magnetic resonance spectroscopy (MRS).	Baseline and 12 months.
Brain imaging outcomes - Brain function (BOLD signal activity)	Change from baseline in brain activity measured using functional magnetic resonance imaging (fMRI).	Baseline and 12 months.
Serum vasoactive intestinal peptide (VIP) and inflammatory marker concentrations	Change from baseline in serum vasoactive intestinal peptide (VIP) and inflammatory marker concentrations, including tumor necrosis factor alpha (TNF-α).	Baseline and 12 months.

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: Ostergotland County Council, Sweden; The Kamprad Family Foundation for Entrepreneurship, Research & Charity

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: April 11, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: DNR201902932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We can share our data on demand of researchers, but first after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No