Identifying biomarkers for 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
This study is trying to find specific markers in blood and stool that can help tell if someone has inflammatory bowel disease, like Crohn's or ulcerative colitis, and will follow participants for a year to see how well it works.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 17 sites (Aabenraa and 16 other locations) |
| Trial ID | NCT05414578 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify molecular markers in blood and stool samples that can help differentiate individuals diagnosed with inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis, from those without the condition. Participants suspected of having IBD will be evaluated at baseline and again after one year to assess diagnosis and clinical outcomes. The study also seeks to incorporate clinical and lifestyle factors to enhance the predictive potential for identifying IBD and understanding its prognosis. Conducted across multiple centers in the Nordic region, the study will include up to 800 participants over a one-year period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been referred to a gastroenterology department due to suspicion of inflammatory bowel disease.
Not a fit: Patients with a previous diagnosis of Crohn's disease, ulcerative colitis, or IBD unclassified will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and personalized treatment strategies for patients with inflammatory bowel disease.
How similar studies have performed: Other studies have shown promise in using biomarkers for diagnosing inflammatory bowel diseases, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Aabenraa and 16 other locations
- University Hospital of Southern Denmark — Aabenraa, Denmark (Not_yet_recruiting)
- SVS Esbjerg Hospital — Esbjerg, Denmark (Not_yet_recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- OUH Svendborg Hospital — Svendborg, Denmark (Recruiting)
- SLB Vejle Hospital — Vejle, Denmark (Recruiting)
- Landspitali — Reykjavík, Iceland (Recruiting)
- Vestre Viken HF — Drammen, Norway (Recruiting)
- Østfold Kalnes — Grålum, Norway (Recruiting)
- Oslo Universitetssykehus — Oslo, Norway (Recruiting)
- Sykehuset i Telemark — Skien, Norway (Recruiting)
- Sykehuset i Vestfold — Tønsberg, Norway (Recruiting)
- Höglandssjukhuset Eksjö — Eksjö, Region Jönköpings Län, Sweden (Recruiting)
- Karolinska Universitetssjukhuset — Stockholm, Region Stockholm, Sweden (Recruiting)
- Akademiska Sjukhuset Uppsala — Uppsala, Region Uppsala, Sweden (Recruiting)
- Universitetssjukhuset i Linköping — Linköping, Region Östergötland, Sweden (Recruiting)
- Ersta Sjukhus — Stockholm, Sweden (Recruiting)
- Universitetssjukhuset Örebro — Örebro, Örebro Län, Sweden (Recruiting)
Study contacts
- Principal investigator: Jens Kjeldsen, Professor — Odense University Hospital
- Study coordinator: Vibeke Andersen, Professor
- Email: va@rsyd.dk
- Phone: 0045 2115 7790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.