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Clinical Trials in Belgium / NCT06900738
Starting soon Not applicable

A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD

NCT06900738 · tracked via the Priya Life Science Belgium tracker
Sponsor
Universitaire Ziekenhuizen KU Leuven
Phase
Not applicable
Started
2025-10-01
Last updated
2025-03-28

Condition(s) studied

Inflammatory Bowel Disease (IBD)Ulcerative Colitis (UC)Crohn Disease (CD)

Investigational drug(s) / intervention(s)

Inflammometer

Inflammometer: Patients wear an inflammometer for Photoplethysmography measurements.

Study 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 hemorheology) to inflammatory processes. NimBio's technology analyses blood flow properties using photoplethysmography (PPG), an optical signal, which detects blood flow changes in the microvascular bed of tissues. The PPG signal is obtained from a commercially available wearable (bracelet) which is convenient for the patients. Based on the impact of inflammation on parameters influencing hemorheology (mainly blood vessel stiffness, blood viscosity and red blood cell aggregation) and the fact that the PPG signal mirrors blood flow characteristics, PPG measurements are associated with changes in inflammatory biomarkers and therefore correlate with disease activity.

This offers a possibility for continuous, non-invasive monitoring of inflammation. The study aims to further validate the NimBio Inflammometer and its value for monitoring inflammatory changes and dynamics in patients with IBD at the University Hospitals Leuven.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital Leuven Leuven Belgium

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Other trials for the same condition

Personalized Exercise Coaching to Improve Quality of Life in Pediatric IBD Active, not recruiting
A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease Recruiting
Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context Recruiting
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis Active, not recruiting
Multiple Digital Biomarkers for Optimization of IBD Care Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06900738 on ClinicalTrials.gov ↗ ← All trials in Belgium