Using a camera pill to diagnose 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
This study is testing whether a camera pill can help diagnose Crohn's disease in young adults who might have it, comparing it to traditional methods like colonoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark Academic / other |
| Locations | 5 sites (Esbjerg and 4 other locations) |
| Trial ID | NCT06882993 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility of using a camera pill examination of the whole bowel as a diagnostic tool for Crohn's disease in patients aged 18-40 years who are suspected of having the condition. Participants will undergo either the camera pill examination or traditional colonoscopy and small bowel examination. The study will assess how many patients can be diagnosed with Crohn's disease using the camera pill without needing further examinations. Researchers will also monitor participants' health through interviews and medical record checks over time.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-40 with clinical suspicion of Crohn's disease based on specific gastrointestinal symptoms and laboratory findings.
Not a fit: Patients with previous intestinal resections or those with positive serologic markers for celiac disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more efficient method for diagnosing Crohn's disease.
How similar studies have performed: Other studies have shown promise in using capsule endoscopy for gastrointestinal diagnostics, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Esbjerg and 4 other locations
- Esbjerg Hospital - University Hospital of Southern Denmark — Esbjerg, Denmark (Recruiting)
- Odense University Hospital — Odense C, Denmark (Recruiting)
- Odense University Hospital - Svendborg Hospital — Svendborg, Denmark (Not_yet_recruiting)
- Lillebaelt Hospital Vejle - University Hospital of Southern Denmark — Vejle, Denmark (Recruiting)
- Skåne University Hospital — Malmö, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Frederik D Thrane, MD — Esbjerg Hospital - University Hospital of Southern Denmark
- Study coordinator: Frederik D Thrane, MD
- Email: Frederik.Drejer.Thrane2@rsyd.dk
- Phone: 0045 79183140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.