Clinical trial NCT06882993: Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn's Disease
Keywords: capsule endoscopy
panenteric capsule endoscopy
Crohn&amp;#39;s disease
inflammatory bowel disease
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Svendborg Hospital
name: Skane University Hospital
name: Vejle Hospital
First posted: 2025-03-19
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Primary outcomes:
measure: Diagnostic completeness
timeFrame: Immediately after initial diagnostic procedure
Secondary outcomes:
measure: Feasibility of pan-enteric CE
timeFrame: After completion of follow-up (12 months)
measure: Additional examinations
timeFrame: After completion of follow-up (12 months)
measure: Safety
timeFrame: After completion of follow-up (12 months)
measure: Time to diagnosis
timeFrame: After completion of follow-up (12 months)
measure: Disease classification and medical treatments
timeFrame: After completion of follow-up (12 months)
measure: Patient satisfaction
timeFrame: Immediately after initial diagnostic procedure
measure: Costs
timeFrame: After completion of follow-up (12 months)
measure: Artificial intelligence
timeFrame: Immediately after initial diagnostic procedure
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital - University Hospital of Southern Denmark
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Svendborg
country: Denmark
facility: Odense University Hospital - Svendborg Hospital
city: Vejle
country: Denmark
facility: Lillebaelt Hospital Vejle - University Hospital of Southern Denmark
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Esbjerg Hospital - University Hospital of Southern Denmark
name: Frederik D Thrane, MD
role: PRINCIPAL_INVESTIGATOR
References: