Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Recruiting · NCT06882993 · Interventional (participants receive a specific treatment) · Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease. The main question it aims to answer is: How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations? Researchers will compare with patients examined with colonoscopy and a small bowel examination. Participants will: * Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination * Have their electronic medical records checked to see if a diagnosis has been made * Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
5 locations listed.
- Esbjerg Hospital - University Hospital of Southern Denmark - Esbjerg, Denmark
- Skåne University Hospital - Malmö, Sweden
- Odense University Hospital - Odense C, Denmark
- Odense University Hospital - Svendborg Hospital - Svendborg, Denmark
- Lillebaelt Hospital Vejle - University Hospital of Southern Denmark - Vejle, Denmark