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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Mar 21, 2025

Keywords

ClinConnect 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 hemorheo...

Gender

ALL

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