Clinical trial NCT06900738: A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD
Official title: A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease (IBD)
Ulcerative Colitis (UC)
Crohn Disease (CD)
Keywords: inflammatory biomarker
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: NimBio
First posted: 2025-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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-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.

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-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 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

Primary outcomes:
measure: Correlation of the the PPG signal with any dynamic biomarker
timeFrame: 6 months
Secondary outcomes:
measure: Correlation of the PPG signal with the patient inflammatory status
timeFrame: 6 months
measure: Classification of the inflammatory status based on the PPG signal
timeFrame: 6 months
measure: Correlation of the inflammatory trajectory with the patient's inflammatory status
timeFrame: 6 months
measure: Classification of the inflammatory status compared to the clinical disease activity
timeFrame: 6 months
measure: Time of NimBio's indication of a change in the inflammatory status
timeFrame: 6 months
measure: Assessment of physiological parameters
timeFrame: 6 months
measure: Assessment of patient satisfaction
timeFrame: 6 months
measure: Assessment of the correlation between the inflammatory status and disease activity
timeFrame: 6 months
measure: The effect of the integration of physiological parameters into NimBio's algorithm
timeFrame: 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
References: