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NORDTREAT Prospective Study on Inflammatory Bowel Disease

The Nordic IBD Study Within Personalized Medicine - Diagnosing and Prediction Using Molecular Characterization of Inflammatory Bowel Disease: the NORDTREAT Prospective Cohort Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Inflammatory bowel disease (IBD), primarily ulcerative colitis (UC) and Crohn's disease (CD), is a chronic disease entity affecting individuals of all ages, and which may severely impact the lives of the patients and their families as well as society. Individuals with IBD may have to live with relapsing symptoms, such as diarrhea, abdominal pain, and fatigue. Further, a substantial proportion of patients develop serious complications such as bowel obstruction and fistula, and some develop complicating liver disease and eventually colorectal cancer. The consequences are that many patients suffer hospitalizations, recurring sick-leave, life-long medication, and surgical interventions. As IBD has become increasingly common in Western populations there is a clear need to improve the outcome from IBD. IBD is a heterogeneous disease entity with substantial differences between patients and personalized medicine may help provide strategies for better treatment . Currently, one of the main unmet needs is the glaring lack of robust biomarkers for individual disease characterization. This lack leads to delayed diagnosis, worse outcomes, increased mortality and an amplified disease burden. Furthermore, diagnosis of IBD is difficult and early diagnosis is crucial as it helps avoid the development of irreversible organ damage. Therefore, there is an emerging focus on the development of simple, non-invasive, and cheap biomarkers to support clinical decision-making in IBD. This Nordic, prospective, clinical study has the aim of identifying markers that are associated with the diagnosis of IBD and prediction of clinical outcomes with various disease manifestations. Importantly, this study will evaluate the markers in a relevant clinical setting, i.e. among patients referred to the hospital for suspicion on IBD using the ECCO Criteria. Specifically the aims of the study are to: * Improve the accuracy to diagnose IBD * Improve the accuracy to define the prognosis of IBD The study is approved by the local Ethics Committee (S-20200051) and the local Data Agency (20/54594).

Who May Be Eligible (Plain English)

To be included in the study, the participants must meet the following criteria: Who May Qualify: - Referred on the suspicion of inflammatory bowel disease - Adult (+18 years of age) - Written willing to sign a consent form to participate in the study Who Should NOT Join This Trial: - A previous known diagnosis of Crohn's disease, ulcerative colitis or IBD-U - Unable to provide willing to sign a consent form - Unable to comply with protocol requirements (e.g., for reasons including alcohol and/or recreational drug abuse) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
To be included in the study, the participants must meet the following criteria: Inclusion Criteria: * Referred on the suspicion of inflammatory bowel disease * Adult (+18 years of age) * Written informed consent to participate in the study Exclusion Criteria: * A previous known diagnosis of Crohn's disease, ulcerative colitis or IBD-U * Unable to provide informed consent * Unable to comply with protocol requirements (e.g., for reasons including alcohol and/or recreational drug abuse)

Locations (17)

University Hospital of Southern Denmark
Aabenraa, Denmark
SVS Esbjerg Hospital
Esbjerg, Denmark
Odense University Hospital
Odense, Denmark
OUH Svendborg Hospital
Svendborg, Denmark
SLB Vejle Hospital
Vejle, Denmark
Landspitali
Reykjavik, Iceland
Vestre Viken HF
Drammen, Norway
Østfold Kalnes
Grålum, Norway
Oslo Universitetssykehus
Oslo, Norway
Sykehuset i Telemark
Skien, Norway
Sykehuset i Vestfold
Tønsberg, Norway
Höglandssjukhuset Eksjö
Eksjö, Region Jönköpings Län, Sweden
Karolinska Universitetssjukhuset
Stockholm, Region Stockholm, Sweden
Akademiska Sjukhuset Uppsala
Uppsala, Region Uppsala, Sweden
Universitetssjukhuset i Linköping
Linköping, Region Östergötland, Sweden
Ersta Sjukhus
Stockholm, Sweden
Universitetssjukhuset Örebro
Örebro, Örebro County, Sweden