IBD Clinical Trial
— SUSIOfficial title:
Management of Inflammatory Bowel Disease in the Stavanger Area - a Prospective Evaluation of Standardized Treatment Regimens on Disease Outcome With Focus on Mucosal Healing and Associations to Fatigue
| NCT number | NCT01551563 |
| Other study ID # | SUSI_1 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2012 |
| Est. completion date | December 2030 |
| Verified date | November 2023 |
| Source | Helse Stavanger HF |
| Contact | tore grimstad |
| tore.bjorn.grimstad[@]sus.no | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined. Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.
| Status | Recruiting |
| Enrollment | 700 |
| Est. completion date | December 2030 |
| Est. primary completion date | December 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 80 Years |
| Eligibility | Inclusion Criteria: - newly diagnosed IBD Exclusion Criteria: - previous IBD with specific treatment within 10 year - inability to consent - inability to adhere to treatment protocol |
| Country | Name | City | State |
|---|---|---|---|
| Norway | SUS | Stavanger |
| Lead Sponsor | Collaborator |
|---|---|
| Helse Stavanger HF |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical efficacy of IBD drug therapy | Endoscopic, clinical and biochemical response | 5 years | |
| Secondary | Fatigue in patients with coeliac disease - substudy | Fatigue severity and prevalence at diagnosis and after one year of gluten free diet | 1 year | |
| Secondary | Fatigue in IBD | Fatigue severity and prevalence at diagnosis and during follow-up | 5 years | |
| Secondary | IBD and the intestinal microbiome | Microbiome/eukaryome profiles associated with disease activity and treatment response from diagnosis and during follow-up | 5 years |
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