Stavanger University Hospital Inflammatory Bowel Disease Trial
SUSI
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
1 other identifier
observational
700
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
May 16, 2025
May 1, 2025
14.7 years
March 8, 2012
May 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical efficacy of IBD drug therapy
Endoscopic, clinical and biochemical response
5 years
Secondary Outcomes (3)
Fatigue in patients with coeliac disease - substudy
1 year
Fatigue in IBD
5 years
IBD and the intestinal microbiome
5 years
Eligibility Criteria
All newly diagnosed IBD patients (Crohns and Ulcerative colitis) within Stavanger Univ Hospital catchment area
You may qualify if:
- newly diagnosed IBD
You may not qualify if:
- previous IBD with specific treatment within 10 year
- inability to consent
- inability to adhere to treatment protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUS
Stavanger, Norway
Related Publications (3)
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: 37766922DERIVEDGrimstad 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: 28040992DERIVEDGrimstad 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: 25994356DERIVED
Biospecimen
Plasma and mucosal biopsies Fecal sampling
Study Officials
- PRINCIPAL INVESTIGATOR
Tore Grimstad, PhD
Helse Stavanger HF
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2012
First Posted
March 12, 2012
Study Start
April 1, 2012
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2030
Last Updated
May 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share