Actively Recruiting
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Led by Esbjerg Hospital - University Hospital of Southern Denmark · Updated on 2025-03-19
165
Participants Needed
5
Research Sites
183 weeks
Total Duration
On this page
Sponsors
E
Esbjerg Hospital - University Hospital of Southern Denmark
Lead Sponsor
O
Odense University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical suspicion of Crohn's disease based on diarrhea and/or abdominal pain for more than 1 month or repeated episodes
- Fecal calprotectin level ≥ 200 mg/kg, or fecal calprotectin ≥ 50 mg/kg plus at least one of the following: elevated C-reactive protein (> 5 mg/L), thrombocytosis (> 400 x 10^9/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 usual level), prolonged fever (> 37.5 °C for more than 2 weeks), weight loss (≥ 3 kg or ≥ 5% of normal body weight), perianal abscess or fistula, or family history of inflammatory bowel disease
- Age between 18 and 40 years
- Signed informed consent
You will not qualify if you...
- Previous intestinal resection
- Positive serologic markers for celiac disease
- Positive stool tests for pathogenic bacteria or intestinal parasites
- Suspected or confirmed acute bowel obstruction (ileus)
- Use of NSAIDs or acetylsalicylic acid (except low-dose prophylactic acetylsalicylic acid ≤ 150 mg/day) within 4 weeks before joining the study
- Use of opioid or opioid-like medications within 1 week before joining the study
- Pregnancy or lactation
- Unable to follow study procedures due to reasons such as alcohol or recreational drug abuse
- Known gastrointestinal disorders other than functional gastrointestinal disorders
- Renal failure defined by plasma creatinine above the normal reference range
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Esbjerg Hospital - University Hospital of Southern Denmark
Esbjerg, Denmark, 6700
Actively Recruiting
2
Odense University Hospital
Odense C, Denmark, 5000
Actively Recruiting
3
Odense University Hospital - Svendborg Hospital
Svendborg, Denmark, 5700
Not Yet Recruiting
4
Lillebaelt Hospital Vejle - University Hospital of Southern Denmark
Vejle, Denmark, 7100
Actively Recruiting
5
Skåne University Hospital
Malmö, Sweden, 205 02
Not Yet Recruiting
Research Team
F
Frederik D Thrane, MD
CONTACT
M
Michael D Jensen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here