Status:
RECRUITING
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Lead Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborating Sponsors:
Odense University Hospital
Svendborg Hospital
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MR...
Eligibility Criteria
Inclusion
- Clinical suspicion of CD\*
- Age 18-40 years
- Signed informed consent
- \*A clinical suspicion of CD is based on the following definition:
- Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either
- fecal calprotectin ≥ 200 mg/kg or
- fecal calprotectin ≥ 50 mg/kg plus one or more of the following findings:
- C-reactive protein (CRP) \> 5 mg/L
- Thrombocytosis (\> 400 x 109/L)
- Anemia (hemoglobin \< 7.0 mmol/L for women and \< 8.0 mmol/L for men or a decrease \> 0.5 mmol/L compared to the usual level)
- Prolonged fever (\> 37.5 ◦C for more than 2 weeks)
- Weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight)
- Perianal abscess / fistula
- Family history of inflammatory bowel disease.
Exclusion
- Previous intestinal resection
- Positive serologic markers for celiac disease
- Positive stool polymerase chain reaction for pathogenic bacteria
- Positive stool polymerase chain reaction for intestinal parasites
- Suspected or established acute bowel obstruction (ileus)
- Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion, except low-dose, prophylactic acetylsalicylic acid (≤ 150 mg per day)
- Intake of opioid or opioid-like medications ≤ 1 week before inclusion
- Pregnancy or lactation
- Inability to comply with protocol requirements, e.g. for reasons including alcohol or recreational drug abuse
- Known gastrointestinal disorder other than functional gastrointestinal disorders
- Renal failure defined by a plasma-creatinine above the normal reference range
Key Trial Info
Start Date :
February 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06882993
Start Date
February 26 2025
End Date
August 31 2028
Last Update
March 19 2025
Active Locations (5)
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1
Esbjerg Hospital - University Hospital of Southern Denmark
Esbjerg, Denmark, 6700
2
Odense University Hospital
Odense C, Denmark, 5000
3
Odense University Hospital - Svendborg Hospital
Svendborg, Denmark, 5700
4
Lillebaelt Hospital Vejle - University Hospital of Southern Denmark
Vejle, Denmark, 7100