A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD
Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Mar 21, 2025
Trial Information
Current as of April 23, 2025
Not yet recruiting
Keywords
ClinConnect 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-reactive protein (CRP) and faecal calprotectin are useful but are either invasive or disliked by patients and a proper continuous monitoring is not feasible with fragmented biomarker information.
The NimBio technology provides support for the clinicians who are managing IBD patients' care based on a wearable technology that allows tracking responsiveness of blood flow properties (also called hemorheo...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- • 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- • 3. Diagnosis of IBD (Crohn's disease or ulcerative colitis) or IBDU
- 4. Hospitalized or ambulatory patients with active IBD defined as:
- • 1. HBI ≥ 5, or PMS score ≥3, and
- • 2. Faecal Calprotectin ≥200 μg/g or CRP \> 10 mg/ml, and
- • 3. Access to iOS or Android-based smartphone with internet access
- • 5. 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 Criteria:
- • 1. Pregnancy
- • 2. Allergy to steel or elastomer/rubber
- • 3. Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment
About Universitaire Ziekenhuizen Ku Leuven
Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, , Belgium
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported