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| Name | Class |
|---|---|
| Ostergotland County Council, Sweden | OTHER |
| The Kamprad Family Foundation for Entrepreneurship, Research & Charity | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University Hospital | Linköping | Linköping | 58185 | Sweden |
We can share our data on demand of researchers, but first after publication
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Dietician module | Other | Individualized dietician guided treatment with either lowFODMAP diet or traditional IBS dietary advice. |
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| 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. |
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| 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. |
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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. |
| D004066 | Digestive System Diseases |