Multiple Digital Biomarkers for Optimization of IBD Care

Not yet recruiting

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

• Registration Number: NCT07159776
• Lead Sponsor: Imelda GI Clinical Research Center

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, laboratory data and technical exam data. A model will be build that predict disease activity in IBD.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-23
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study Start: 2025-09-08
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients in which a flare can be detected based on passive monitoring data.	1 year

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in which a biomarker flare can be detected based on passive monitoring data	1 year
Proportion of patients in which a biomarker flare can be detected based on food purchase data	1 year
Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on passive monitoring	1 year
Proportion of patients in which a flare can be detected based on food purchase data	1 year
Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on food purchase data	1 year

Trial Locations

Locations (1)

Imelda General Hospital; 🇧🇪 Bonheiden, Belgium