Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease (ANDI)
Crohn Disease
About this trial
This is an interventional diagnostic trial for Crohn Disease focused on measuring Capsule endoscopy, Crohn's disease, Magnetic resonance enterography, Ileocolonoscopy, Bowel Ultrasound, diagnostic imaging
Eligibility Criteria
Inclusion Criteria:
General criterion
All of the following:
- Clinical suspicion of CD
- Age > 15 years
- Negative serologic markers for celiac disease, negative stool culture (or polymerase chain reaction) for pathogenic bacteria and a negative microscopy for intestinal parasites
- Fecal calprotectin > 50 mg/kg
- Signed informed consent
Clinical criterion Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) associated with one or more of the following findings: (1) C-reactive protein (CRP) >5 mg/L, (2) 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), (3) prolonged fever (> 37.5 C for more than 2 weeks), (5) weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight), (6) perianal abscess/fistula, or (7) a family history of inflammatory bowel disease.
Exclusion Criteria:
- Acute bowel obstruction
- Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion except prophylactic treatment with low dose Aspirin (≤ 150 mg per day)
- Pregnancy or lactation
- Alcohol or drug abuse
- Known gastrointestinal disorder other than inflammatory bowel disease
- Renal failure defined by a plasma-creatinine above the normal reference range
- Claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes MREC
- Interpreter required or inability to understand the oral and written information
- Colonoscopy contraindicated, performed within 3 months or unwillingness to go through colonoscopy
Sites / Locations
- Sydvestjysk sygehus
- Odense university Hospital
- Sygehus Lillebaelt
Arms of the Study
Arm 1
Other
trial participant
All participants undergoes the same diagnostic imaging