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

NCT06900738 | Not Yet Recruiting

• 1 other identifier: VERSATILE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

inflammatory biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Correlation of the PPG signal with the patient inflammatory status

  6 months

• Classification of the inflammatory status based on the PPG signal

  6 months

• Correlation of the inflammatory trajectory with the patient's inflammatory status

  6 months

• Classification of the inflammatory status compared to the clinical disease activity

  6 months

• Time of NimBio's indication of a change in the inflammatory status

  6 months

Study Arms (1)

IBD patients with inflammometer

OTHER

blood samples, stool samples, questionnaires and inflammometer measurements

Device: Inflammometer

Interventions

Inflammometer DEVICE

Patients wear an inflammometer for Photoplethysmography measurements.

Also known as: inflammatory biomarkers, Photoplethysmography

IBD patients with inflammometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Allergy to steel or elastomer/rubber
• Using a pacemaker, implantable cardiac defibrillator, neurostimulator, or other electronic medical equipment

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• NimBio: collaborator

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Interventions

Photoplethysmography

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Plethysmography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Marc Ferrante, Prof Dr

CONTACT

016342845; marc.ferrante@uzleuven.be

Stefan Delen, Dr

CONTACT

stefandelen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Marc Ferrante

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 28, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-02

Locations

BE (1)