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

Not Applicable

Not yet recruiting

• Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn Disease (CD)

• Registration Number: NCT06900738
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation of the the PPG signal with any dynamic biomarker	6 months	Correlation of the inflammatory dynamics (trajectory) as measured by NimBio's technology with any dynamic biomarker in the IBD patient population

Secondary Outcome Measures

Name	Time	Method
Correlation of the PPG signal with the patient inflammatory status	6 months	Correlation of the inflammatory dynamics as measured by NimBio's technology with the patient inflammatory status as defined by any dynamic biomarker as compared to each individual biomarker in the overall IBD patient population.
Classification of the inflammatory status based on the PPG signal	6 months	Classification of the inflammatory status as inflamed vs non-inflamed based on NimBio's technology as defined by increase of 1.5-fold over the upper normal limit
Correlation of the inflammatory trajectory with the patient's inflammatory status	6 months	Correlation of the inflammatory trajectory as defined by NimBio's technology with the patient's inflammatory status as assessed by HBI, PRO-2, PMS and SCCAI
Classification of the inflammatory status compared to the clinical disease activity	6 months	Classification of the inflammatory status as inflamed vs non-inflamed based on NimBio's technology compared to the clinical disease activity measured by disease activity questionnaires (where inflammation is defined as HBI\> 5 and PMS\>3).
Time of NimBio's indication of a change in the inflammatory status	6 months	The time of NimBio's indication of a change in the inflammatory status compared with the time of change in the clinical disease score or a physician instructed treatment modification
Assessment of physiological parameters	6 months	Assessment of physiological parameters such as pulse rate, as measured by non-invasive measurements
Assessment of patient satisfaction	6 months	Assessment of patient satisfaction about the wearable with PREM questionnaire
Assessment of the correlation between the inflammatory status and disease activity	6 months	Assessment of the correlation between the inflammatory status determined by NimBio's technology and disease activity as measured by endoscopy
The effect of the integration of physiological parameters into NimBio's algorithm	6 months	The effect of the integration of physiological parameters such as pulse rate into NimBio's algorithm as compared to at least one inflammatory biomarker reflecting the patient's inflammatory status

Trial Locations

Locations (1)

University Hospital Leuven; 🇧🇪 Leuven, Belgium