DGBI, IBS (Irritable Bowel Syndrome)
Conditions
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).
Interventions
OTHERPhysician-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.
OTHERDietician module
Individualized dietician guided treatment with either lowFODMAP diet or traditional IBS dietary advice.
OTHERPsychologist 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.
OTHERPhysiotherapy 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.
Sponsors
Linkoeping University
Ostergotland County Council, Sweden
The Kamprad Family Foundation for Entrepreneurship, Research & Charity
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IBS symptom severity score | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Gastrointestinal symptom severity | 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). |
| Psychological symptom burden | 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. |
| Visceral sensitivity index (VSI) | 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. |
| Changes in Gut-brain axis physiology | 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. |
| Brain imaging outcomes - Brain Structure | At the baseline and after 12 months. | Change from baseline in regional gray matter volume measured using structural magnetic resonance imaging (MRI). |
| Brain imaging outcomes - Brain neurochemistry | Baseline and 12 months. | Change from baseline in brain metabolite, in insula, such as GABA concentrations measured using magnetic resonance spectroscopy (MRS). |
| Brain imaging outcomes - Brain function (BOLD signal activity) | Baseline and 12 months. | Change from baseline in brain activity measured using functional magnetic resonance imaging (fMRI). |
| Serum vasoactive intestinal peptide (VIP) and inflammatory marker concentrations | Baseline and 12 months. | Change from baseline in serum vasoactive intestinal peptide (VIP) and inflammatory marker concentrations, including tumor necrosis factor alpha (TNF-α). |
Countries
Sweden
Outcome results
None listed