Multiple Digital Biomarkers for Optimization of IBD Care
Observational · No treatment assigned · 1 site · Imelda GI Clinical Research Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD), Ulcerative Colitis (UC) and Inflammatory Bowel Disease (IBD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Males or females aged > 18 years
- Diagnosis of CD, UC or IBD-unspecified for at least 1 month
- Treatment with conventional or advanced therapy for IBD at initiation of the study
Plus 4 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2025-09-08 (planned).
- Main results expected around 2026-09-30 (estimate from the record).
- 1 study site listed in Belgium.
Main thing being measured
- Proportion of patients in which a flare can be detected based on passive monitoring data. (1 year)
In the researchers’ words
To develop digital biomarkers associated with disease activity of inflammatory bowel disease
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 | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Disease (IBD) |
| Lead sponsor | Imelda GI Clinical Research Center |
| Collaborators | Agentschap Innoveren & Ondernemen (VLAIO) |
| Enrollment | 80 (estimated) |
| Start date | 2025-09-08 |
| Primary completion (est.) | 2026-09-30 |
| First posted | 2025-09-08 |
| Last updated | 2025-09-08 |
| Official title | Multiple Digital Biomarkers for Optimization of IBD Care |
| ClinicalTrials.gov ID | NCT07159776 |
Interventions
- monitoring of wearable data, shopping data, biomarkers and patient reported outcomes (Device)
1. All participants will receive a wearable device type Corsano Health Cardio watch 287-2 which is provided by the sponsor via Inovigate. Participants will be encouraged to wear the device 24h per day and need to wear the wearable device at least 12 hours per day, preferential during daytime. 2. All participants will receive a loyalty card (Xtra card Colruyt group) which is provided by the sponsor…
Full eligibility criteria (from the record)
Inclusion Criteria: * Males or females aged > 18 years * Diagnosis of CD, UC or IBD-unspecified for at least 1 month * Treatment with conventional or advanced therapy for IBD at initiation of the study * The patient must have access to an email address * The patient must be willing to perform all the groceries shopping at any of the Colruyt Group stores during this study, using an Xtra card created by the study team. * Capacity to independently answer regular digital questionnaires * Capacity and willingness to use a smartphone and activity tracker Exclusion Criteria: * Planned extended (> 1 month) overseas travel during the study period of 12 months, if internet access would be impossible, inconvenient or unaffordable during this time * Previous colectomy * Inability to communicate well with investigators or unable to comply with the study requirements * Significant medical condition interfering with physiological measurements trough a wearable device (heart failure, pacemaker or defibrillator) * Inclusion or planned inclusion in an interventional IBD-related clinical trial
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Imelda General Hospital | Bonheiden | 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.