NCT06900738Not yet recruiting
A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD
Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 14 Mar 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06900738
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Oct 2025 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy to steel or elastomer/rubber
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.