Using a camera pill to diagnose Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Esbjerg Hospital - University Hospital of Southern Denmark
  Esbjerg, Denmark Recruiting
• Odense University Hospital
  Odense C, Denmark Recruiting
• Odense University Hospital - Svendborg Hospital
  Svendborg, Denmark Recruiting
• Lillebaelt Hospital Vejle - University Hospital of Southern Denmark
  Vejle, Denmark Recruiting
• Skåne University Hospital
  Malmö, Sweden 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.