Status:
NOT_YET_RECRUITING
A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
NimBio
Conditions:
Inflammatory Bowel Disease (IBD)
Ulcerative Colitis (UC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with IBD, including both Crohn's disease and ulcerative colitis, require accurate monitoring of intestinal inflammation for optimal follow-up and treatment. Traditional markers like C-reactiv...
Detailed Description
Patients with IBD, including both Crohn's disease and ulcerative colitis, require accurate monitoring of intestinal inflammation for optimal follow-up and treatment. Traditional markers like C-reactiv...
Eligibility Criteria
Inclusion
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Diagnosis of IBD (Crohn's disease or ulcerative colitis) or IBDU
- Hospitalized or ambulatory patients with active IBD defined as:
- HBI ≥ 5, or PMS score ≥3, and
- Faecal Calprotectin ≥200 μg/g or CRP \> 10 mg/ml, and
- Access to iOS or Android-based smartphone with internet access
- Ambulatory patients would be recruited to the study with a gender ratio that will not deviate from a 40:60 ratio in favor of either gender
Exclusion
- Pregnancy
- Allergy to steel or elastomer/rubber
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06900738
Start Date
October 1 2025
End Date
October 1 2026
Last Update
March 28 2025
Active Locations (1)
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1
University Hospital Leuven
Leuven, Belgium, 3000