NCT06882993Recruiting
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- First submitted
- 26 Feb 2025
- Start date
- 26 Feb 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Diseases
- Crohn's disease
- NCT number
- NCT06882993
What you commit to
- Study type: Interventional
- Planned participants: 165
- From 26 Feb 2025 to the primary completion date, 31 Aug 2027
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous intestinal resection
- 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
- Inability to comply with protocol requirements, e.g. for reasons including alcohol or recreational drug abuse
Other illness
- Positive serologic markers for celiac disease
- Known gastrointestinal disorder other than functional gastrointestinal disorders
Lab values
- Renal failure defined by a plasma-creatinine above the normal reference range
Other
- Positive stool polymerase chain reaction for pathogenic bacteria
- Positive stool polymerase chain reaction for intestinal parasites
- Suspected or established acute bowel obstruction (ileus)
- Pregnancy or lactation
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Esbjerg Hospital, University Hospital of Southern Denmark Coordinator of this site? Confirm its status | Esbjerg | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Odense University Hospital - Svendborg Hospital Coordinator of this site? Confirm its status | Svendborg | Denmark | Recruiting |
| Lillebaelt Hospital Vejle, University Hospital of Southern Denmark Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
| Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.