Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
NCT ID: NCT06882993
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
165 participants
INTERVENTIONAL
2025-02-26
2028-08-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Minimally invasive diagnostic algorithm
Panenteric capsule endoscopy
Panenteric capsule endoscopy
Traditional work-up
Colonoscopy and either MRI enterography or small bowel capsule endoscopy
Ileocolonoscopy
Endoscopic examination of the colon and terminal ileum after bowel preparation.
MRI enterography
MRI of the small bowel
Small bowel capsule endoscopy
Capsule endoscopy of the small bowel
Interventions
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Panenteric capsule endoscopy
Panenteric capsule endoscopy
Ileocolonoscopy
Endoscopic examination of the colon and terminal ileum after bowel preparation.
MRI enterography
MRI of the small bowel
Small bowel capsule endoscopy
Capsule endoscopy of the small bowel
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Svendborg Hospital
OTHER
Skane University Hospital
OTHER
Vejle Hospital
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Responsible Party
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Frederik Drejer Thrane
PhD Student
Principal Investigators
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Frederik D Thrane, MD
Role: PRINCIPAL_INVESTIGATOR
Esbjerg Hospital - University Hospital of Southern Denmark
Locations
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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
Malmo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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24/50881
Identifier Type: -
Identifier Source: org_study_id
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