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

Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark • ClinicalTrials.gov ID: NCT06882993

Registry updated: 2026-09-09

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Description

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

Interventions

Panenteric capsule endoscopy (Diagnostic test)
Panenteric capsule endoscopy
Ileocolonoscopy (Diagnostic test)
Endoscopic examination of the colon and terminal ileum after bowel preparation.
MRI enterography (Diagnostic test)
MRI of the small bowel
Small bowel capsule endoscopy (Diagnostic test)
Capsule endoscopy of the small bowel

Eligibility criteria

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

Conditions

Crohn's Disease

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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