A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD
Not applicable · Testing Inflammometer · 1 site · Universitaire Ziekenhuizen KU Leuven
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Inflammometer (a device). Condition(s) listed: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC) and Crohn Disease (CD).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 5 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2025-10-01 (planned).
- Main results expected around 2026-10-01 (estimate from the record).
- 1 study site listed in Belgium.
Main thing being measured
- Correlation of the the PPG signal with any dynamic biomarker (6 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn Disease (CD) |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Collaborators | NimBio |
| Enrollment | 50 (estimated) |
| Start date | 2025-10-01 |
| Primary completion (est.) | 2026-10-01 |
| First posted | 2025-03-28 |
| Last updated | 2025-03-28 |
| Official title | A Study to Evaluate Non-invasive Measurements of the Inflammatory Status in Patients with IBD |
| ClinicalTrials.gov ID | NCT06900738 |
Interventions
- Inflammometer (Device)
Patients wear an inflammometer for Photoplethysmography measurements.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Leuven | Leuven | Belgium |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.