NCT07159776

Multiple Digital Biomarkers for Optimization of IBD Care

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Imelda GI Clinical Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To develop digital biomarkers associated with disease activity of inflammatory bowel disease

Detailed description

The trial aims to develop digital biomarkers based on a large dataset of imput data. These data come from diffent sources including wearable data, grocery shopping data, patient reported outcome data, laboratory data and technical exam data. A model will be build that predict disease activity in IBD.

Conditions

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

Interventions

Type	Name	Description
DEVICE	monitoring of wearable data, shopping data, biomarkers and patient reported outcomes	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 via Inovigate for food data capturing. The patient is requested to execute all grocery shopping at one of the Colruyt Group stores. He/she will always need to offer the loyalty card to the cashier prior to payment. The purchase receipt will then be automatically sent to the central food data repository at the sponsor set up for this study. Non-food or non-food related data will neither be captured nor stored during the trial. 3. biomarkers in blood and feaces will be monitored according to standard of care 4. patient reported outcomes will be monitored according to standard of care

Timeline

• Start date: 2025-09-08
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: Belgium