Stavanger University Hospital Inflammatory Bowel Disease Trial
ConditionIBD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-80
SponsorHelse Stavanger HF
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
newly diagnosed IBD
Disqualifiers
previous IBD with specific treatment within 10 year
inability to consent
inability to adhere to treatment protocol
Trial population
All newly diagnosed IBD patients (Crohns and Ulcerative colitis) within Stavanger Univ Hospital catchment area
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Clinical efficacy of IBD drug therapy
Endoscopic, clinical and biochemical response
Time frame
5 yearsSecondary outcomes
1
Fatigue in patients with coeliac disease - substudy
Fatigue severity and prevalence at diagnosis and after one year of gluten free diet
Time frame
1 year2
Fatigue in IBD
Fatigue severity and prevalence at diagnosis and during follow-up
Time frame
5 years3
IBD and the intestinal microbiome
Microbiome/eukaryome profiles associated with disease activity and treatment response from diagnosis and during follow-up
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov