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

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 Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Disease (IBD); Crohn Disease (CD); Ulcerative Colitis (UC)
• Intervention / Treatment: Device: Inflammometer

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Ferrante, Prof Dr; Phone Number: +32 016342845; Email: marc.ferrante@uzleuven.be
• Study Contact Backup: Name: Stefan Delen, Dr; Email: stefandelen@hotmail.com

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospital Leuven
    • Contact: Marc Ferrante, Prof Dr; Phone Number: +32 016342845; Email: marc.ferrante@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IBD patients with inflammometer; blood samples, stool samples, questionnaires and inflammometer measurements	Device: Inflammometer; Patients wear an inflammometer for Photoplethysmography measurements.; Other Names: inflammatory biomarkers; Photoplethysmography

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the PPG signal with the patient inflammatory status	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.	6 months
Classification of the inflammatory status based on the PPG signal	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	6 months
Correlation of the inflammatory trajectory with the patient's inflammatory status	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	6 months
Classification of the inflammatory status compared to the clinical disease activity	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).	6 months
Time of NimBio's indication of a change in the inflammatory status	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	6 months
Assessment of physiological parameters	Assessment of physiological parameters such as pulse rate, as measured by non-invasive measurements	6 months
Assessment of patient satisfaction	Assessment of patient satisfaction about the wearable with PREM questionnaire	6 months
Assessment of the correlation between the inflammatory status and disease activity	Assessment of the correlation between the inflammatory status determined by NimBio's technology and disease activity as measured by endoscopy	6 months
The effect of the integration of physiological parameters into NimBio's algorithm	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	6 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: NimBio

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: inflammatory biomarker
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: VERSATILE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No