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

Not Applicable

Recruiting

• Conditions: Crohn's Disease

• Registration Number: NCT06882993
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-26
• Study First Submitted: 2025-02-26
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnostic completeness	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 Outcome Measures

Name	Time	Method
Safety	After completion of follow-up (12 months)	Number of severe adverse events
Time to diagnosis	After completion of follow-up (12 months)	Time from referral or first diagnostic procedure to final diagnosis and treatment
Feasibility of pan-enteric CE	After completion of follow-up (12 months)	Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided
Additional examinations	After completion of follow-up (12 months)	Need for additional examinations in the two randomization arms
Disease classification and medical treatments	After completion of follow-up (12 months)	Disease classification and medical treatments in the two randomization arms
Patient satisfaction	Immediately after initial diagnostic procedure	Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score
Costs	After completion of follow-up (12 months)	Expenditure on diagnostic procedures, treatment and loss of productivity
Artificial intelligence	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

Trial Locations

Locations (5)

Esbjerg Hospital - University Hospital of Southern Denmark; 🇩🇰 Esbjerg, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark

Odense University Hospital - Svendborg Hospital; 🇩🇰 Svendborg, Denmark

Lillebaelt Hospital Vejle - University Hospital of Southern Denmark; 🇩🇰 Vejle, Denmark

Skåne University Hospital; 🇸🇪 Malmö, Sweden