Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease

Recruiting now · Not applicable

Conditions studied: Crohn's Disease

In brief

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

Key facts

Study ID

NCT06882993

Run by

Esbjerg Hospital - University Hospital of Southern Denmark

People needed

165

Starts

2025-02-26

Expected to finish

2028-08-31

Last updated by the study team

2025-03-19

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Esbjerg Hospital - University Hospital of Southern Denmark — Esbjerg, Denmark (enrolling)
• Odense University Hospital — Odense C, Denmark (enrolling)
• Lillebaelt Hospital Vejle - University Hospital of Southern Denmark — Vejle, Denmark (enrolling)
• Odense University Hospital - Svendborg Hospital — Svendborg, Denmark
• Skåne University Hospital — Malmö, Sweden

Full record on ClinicalTrials.gov

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