Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease - a Prospective Comparison of Pan-Enteric Capsule Endoscopy Versus Ileocolonoscopy Plus MR Enterography or Small-Bowel Capsule Endoscopy
Trial ID: NCT06882993
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-02-26
Completion date: 2028-08-31
Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Collaborators: Odense University Hospital; Svendborg Hospital; Skane University Hospital; Vejle Hospital
Conditions: Crohn's Disease
Interventions: Panenteric capsule endoscopy; Ileocolonoscopy; MRI enterography; Small bowel capsule endoscopy
Locations: Esbjerg Hospital - University Hospital of Southern Denmark; Odense University Hospital; Odense University Hospital - Svendborg Hospital; Lillebaelt Hospital Vejle - University Hospital of Southern Denmark; Skåne University Hospital
Countries: Denmark; Denmark; Denmark; Denmark; Sweden
Enrollment: 165
Age range: 18 Years - 40 Years
Sex: ALL

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 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

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

Outcomes:
Diagnostic completeness