Stavanger University Hospital Inflammatory Bowel Disease Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: IBD. Basic parameters: 16 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Detailed description
none considered needed
Primary outcome measures
- Clinical efficacy of IBD drug therapy [Time frame: 5 years]
Secondary outcome measures (3)
- Fatigue in patients with coeliac disease - substudy [Time frame: 1 year]
- Fatigue in IBD [Time frame: 5 years]
- IBD and the intestinal microbiome [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- newly diagnosed IBD
Exclusion criteria
- previous IBD with specific treatment within 10 year
- inability to consent
- inability to adhere to treatment protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- SUS — Stavanger
Publications
- Skjellerudsveen BM, Omdal R, Hetta AK, Kvaloy JT, Aabakken L, Skoie IM, Grimstad T. Less, but not gone-gluten-free diet effects on fatigue in celiac disease: a prospective controlled study. Front Med (Lausanne). 2023 Sep 12;10:1242512. doi: 10.3389/fmed.2023.1242512. eCollection 2023. PMID 37766922
- Grimstad T, Skoie IM, Doerner J, Isaksen K, Karlsen L, Aabakken L, Omdal R, Putterman C. TWEAK is not elevated in patients with newly diagnosed inflammatory bowel disease. Scand J Gastroenterol. 2017 Apr;52(4):420-424. doi: 10.1080/00365521.2016.1273382. Epub 2016 Dec 31. PMID 28040992
- Grimstad T, Norheim KB, Isaksen K, Leitao K, Hetta AK, Carlsen A, Karlsen LN, Skoie IM, Goransson L, Harboe E, Aabakken L, Omdal R. Fatigue in Newly Diagnosed Inflammatory Bowel Disease. J Crohns Colitis. 2015 Sep;9(9):725-30. doi: 10.1093/ecco-jcc/jjv091. Epub 2015 May 19. PMID 25994356
Identifiers
NCT: NCT01551563 · SUSI_1