Status:
NOT_YET_RECRUITING
Multiple Digital Biomarkers for Optimization of IBD Care
Lead Sponsor:
Imelda GI Clinical Research Center
Collaborating Sponsors:
Agentschap Innoveren & Ondernemen (VLAIO)
Conditions:
Crohn Disease (CD)
Ulcerative Colitis (UC)
Eligibility:
All Genders
18+ years
Brief 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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07159776
Start Date
September 8 2025
End Date
December 31 2026
Last Update
September 8 2025
Active Locations (1)
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1
Imelda General Hospital
Bonheiden, Belgium, 2820