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NCT Number: NCT06882993

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esbjerg Hospital - University Hospital of Southern Denmark, Esbjerg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panenteric capsule endoscopy

Diagnostic Test

Panenteric capsule endoscopy

Ileocolonoscopy

Diagnostic Test

Endoscopic examination of the colon and terminal ileum after bowel preparation.

MRI enterography

Diagnostic Test

MRI of the small bowel

Small bowel capsule endoscopy

Diagnostic Test

Capsule endoscopy of the small bowel

Primary outcomes

  1. Diagnostic completeness

    Time frame: Immediately after initial diagnostic procedure

    Proportion of patients in each arm achieving a complete gastrointestinal assessment and an unambiguous diagnosis after completion of the initial diagnostic procedure(s) without need for supplementary examinations

Secondary outcomes

  1. Feasibility of pan-enteric CE

    Time frame: After completion of follow-up (12 months)

    Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided

  2. Additional examinations

    Time frame: After completion of follow-up (12 months)

    Need for additional examinations in the two randomization arms

  3. Safety

    Time frame: After completion of follow-up (12 months)

    Number of severe adverse events

  4. Time to diagnosis

    Time frame: After completion of follow-up (12 months)

    Time from referral or first diagnostic procedure to final diagnosis and treatment

  5. Disease classification and medical treatments

    Time frame: After completion of follow-up (12 months)

    Disease classification and medical treatments in the two randomization arms

  6. Patient satisfaction

    Time frame: Immediately after initial diagnostic procedure

    Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score

  7. Costs

    Time frame: After completion of follow-up (12 months)

    Expenditure on diagnostic procedures, treatment and loss of productivity

  8. Artificial intelligence

    Time frame: Immediately after initial diagnostic procedure

    Diagnostic utility of AI algorithms in detection of gastrointestinal pathology using pan-enteric CE - sensitivity, specificity, severity, prediction and impact on clinical decision making

Study contacts

Contact information is provided by the study sponsor or research team.

Frederik D Thrane, MD

CONTACT

[email protected]

0045 79183140

Michael D Jensen, MD, PhD

CONTACT

[email protected]

0045 79183140

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • Odense University Hospital
  • Skane University Hospital
  • Svendborg Hospital
  • Vejle Hospital

Registry information

Official study title

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

Acronym: ANDI-3

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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