An interventional study of Physician-module and Dietician module in IBS (Irritable Bowel Syndrome) and DGBI, sponsored by Linkoeping University. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Linkoeping University · Not applicable, Interventional, and Other
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).
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 150 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Dietician module · Other: Psychologist module · Other: Physiotherapy 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.
Individualized dietician guided treatment with either lowFODMAP diet or traditional IBS dietary advice.
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.
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.
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.
Time frame: From enrollment through 1 year after completion of multimodal, multidisciplinary treatment.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 months.
Brain imaging outcomes - Brain Structure
Change from baseline in regional gray matter volume measured using structural magnetic resonance imaging (MRI).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and 12 months.
Plan to share: No — We can share our data on demand of researchers, but first after publication
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Linkoeping University