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

This clinical trial is studying a new way to monitor inflammation in patients with Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. The goal is to test a non-invasive technology called NimBio that uses a wearable device, similar to a bracelet, to track changes in blood flow related to inflammation. This method could provide continuous monitoring without the discomfort of traditional tests, making it easier for patients to keep track of their condition.

To participate in the study, individuals must be at least 18 years old and have an active diagnosis of IBD. They should also be able to provide consent and have access to a smartphone. The study will include both hospitalized and outpatient patients, ensuring a balanced representation of genders. Participants can expect to wear the device and provide data that will help researchers understand how well this new method works for monitoring their disease. It's important to note that pregnant individuals or those with certain medical devices will not be eligible for the trial.

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