Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease

Last updated: March 17, 2025
Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Crohn's Disease

Colic

Inflammatory Bowel Disease

Treatment

MRI enterography

Panenteric capsule endoscopy

Small bowel capsule endoscopy

Clinical Study ID

NCT06882993
24/50881
  • Ages 18-40
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ofdiarrhea 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

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, exceptlow-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 alcoholor recreational drug abuse

  • Known gastrointestinal disorder other than functional gastrointestinal disorders

  • Renal failure defined by a plasma-creatinine above the normal reference range

Study Design

Total Participants: 165
Treatment Group(s): 4
Primary Treatment: MRI enterography
Phase:
Study Start date:
February 26, 2025
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • Esbjerg Hospital - University Hospital of Southern Denmark

    Esbjerg, 6700
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense C, 5000
    Denmark

    Active - Recruiting

  • Odense University Hospital - Svendborg Hospital

    Svendborg, 5700
    Denmark

    Site Not Available

  • Lillebaelt Hospital Vejle - University Hospital of Southern Denmark

    Vejle, 7100
    Denmark

    Active - Recruiting

  • Skåne University Hospital

    Malmö, 205 02
    Sweden

    Site Not Available

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