IBS (Irritable Bowel Syndrome)MagontNCT07534930
Personalised Multidisciplinary Treatment in Moderate to Severe IBS
A study testing Physician-module, Dietician module and Psychologist module in people with IBS (Irritable Bowel Syndrome) and DGBI, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS (Irritable Bowel Syndrome), DGBI
- What is being tested?
- Physician-module, Dietician module and Psychologist module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 23 Sep 2021to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- IBS (Irritable Bowel Syndrome), DGBI
- Being tested
- Physician-module, Dietician module, Psychologist module, Physiotherapy module
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-moduleOther
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 moduleOther
Individualized dietician guided treatment with either lowFODMAP diet or traditional IBS dietary advice.
Psychologist moduleOther
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 moduleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physician-module; Other: Dietician module; Other: Psychologist module; Other: Physiotherapy module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through 1 year after completion of multimodal, multidisciplinary treatment.
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months.
Brain imaging outcomes - Brain Structure
Change from baseline in regional gray matter volume measured using structural magnetic resonance imaging (MRI).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start23 Sep 2021
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS (Irritable Bowel Syndrome)Studies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Ostergotland County Council, Sweden, The Kamprad Family Foundation for Entrepreneurship, Research & Charity
- Responsible party
- Principal investigator, Susanna Walter, Ostergotland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534930
- Sponsor's protocol ID
- DNR201902932
- Acronym
- Magont
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We can share our data on demand of researchers, but first after publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Multidisciplinary Multimodal Treatment in IBS
- ClinicalTrials.gov ID
- NCT07534930
- Acronym / sponsor ID
- Magont / DNR201902932
- Conditions
- IBS (Irritable Bowel Syndrome), DGBI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Ostergotland County Council, Sweden, The Kamprad Family Foundation for Entrepreneurship, Research & Charity
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary multimodal intervention (IBS) | Active comparator | Other: Physician-module, Other: Dietician module, Other: Psychologist module, Other: Physiotherapy moduleSingle-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician-moduleIndividualized medical management by a gastroenterologist targeting predominant IBS symptoms (pain, diarrhea/constipation, bloating) with evidence-based pharmacological and bowel-regulation strategies as needed. | Other | Multidisciplinary multimodal intervention (IBS) |
| Dietician moduleIndividualized dietician guided treatment with either lowFODMAP diet or traditional IBS dietary advice. | Other | Multidisciplinary multimodal intervention (IBS) |
| Psychologist moduleEvidence-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 | Multidisciplinary multimodal intervention (IBS) |
| Physiotherapy moduleTargeted 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. | Other | Multidisciplinary multimodal intervention (IBS) |
Primary outcome
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.
8 secondary outcomes
Changes in Gastrointestinal symptom severity
Time frame: Baseline, 3, 6, 9, and 12 months
Psychological symptom burden
Time frame: At the baseline, 3 months, 6 months, 9 months and end of intervention (12 months)
Visceral sensitivity index (VSI)
Time frame: Baseline, 3, 6, 9, and 12 months
Changes in Gut-brain axis physiology
Time frame: Baseline and 12 months.
Brain imaging outcomes - Brain Structure
Time frame: At the baseline and after 12 months.
Brain imaging outcomes - Brain neurochemistry
Time frame: Baseline and 12 months.
Brain imaging outcomes - Brain function (BOLD signal activity)
Time frame: Baseline and 12 months.
Serum vasoactive intestinal peptide (VIP) and inflammatory marker concentrations
Time frame: Baseline and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. We can share our data on demand of researchers, but first after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-module, Dietician module and Psychologist module in people with IBS (Irritable Bowel Syndrome) and DGBI, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS symptom severity score (time frame: From enrollment through 1 year after completion of multimodal, multidisciplinary treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.