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NCT Number: NCT07534930

Personalised Multidisciplinary Treatment in Moderate to Severe 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

IBS (Irritable Bowel Syndrome) Colonic Diseases Colonic Diseases, Functional DGBI Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University Hospital

Linköping, 58185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Dietician module

Other

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

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.

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.

Primary outcomes

  1. IBS symptom severity score

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

    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.

Secondary outcomes

  1. Changes in Gastrointestinal symptom severity

    Time frame: Baseline, 3, 6, 9, and 12 months

    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).

  2. Psychological symptom burden

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

    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.

  3. Visceral sensitivity index (VSI)

    Time frame: Baseline, 3, 6, 9, and 12 months

    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.

  4. Changes in Gut-brain axis physiology

    Time frame: Baseline and 12 months.

    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.

  5. Brain imaging outcomes - Brain Structure

    Time frame: At the baseline and after 12 months.

    Change from baseline in regional gray matter volume measured using structural magnetic resonance imaging (MRI).

  6. Brain imaging outcomes - Brain neurochemistry

    Time frame: Baseline and 12 months.

    Change from baseline in brain metabolite, in insula, such as GABA concentrations measured using magnetic resonance spectroscopy (MRS).

  7. Brain imaging outcomes - Brain function (BOLD signal activity)

    Time frame: Baseline and 12 months.

    Change from baseline in brain activity measured using functional magnetic resonance imaging (fMRI).

  8. Serum vasoactive intestinal peptide (VIP) and inflammatory marker concentrations

    Time frame: Baseline and 12 months.

    Change from baseline in serum vasoactive intestinal peptide (VIP) and inflammatory marker concentrations, including tumor necrosis factor alpha (TNF-α).

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Ostergotland County Council, Sweden
  • The Kamprad Family Foundation for Entrepreneurship, Research & Charity

Registry information

Official study title

Personalised Multidisciplinary Multimodal Treatment in IBS

Acronym: Magont

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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