An observational study in Crohn Disease (CD), Ulcerative Colitis (UC) and Inflammatory Bowel Disease (IBD), sponsored by Imelda GI Clinical Research Center. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Imelda GI Clinical Research Center · Observational
To develop digital biomarkers associated with disease activity of inflammatory bowel disease
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 80 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Imelda GI Clinical Research Center is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is an open label observational trial with partially blinded data collection (wearable and shopping data blinded for the patient and treating HCP). Patients in the study will not be randomized. Patients will be recruited via planned outpatient visits and day clinic admissions. Patients will be allocated to one of the three target patient groups at the investigator's discretion.
From the moment 60 patients are included, no additional patients can be recruited in group 1 or 3 prior to completion of group 2.
Exclusion Criteria:
1. Patients with IBD in longstanding remission (\>2 years) (maximum of 20 patients) 2. Patients with IBD recent event (diagnosis or flare of IBD) (\<1year) (minimum 20 patients) 3. Additional patients with IBD in standard follow up.
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
Proportion of patients in which a flare can be detected based on passive monitoring data.
Time frame: 1 year
Proportion of patients in which a biomarker flare can be detected based on passive monitoring data
Time frame: 1 year
Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on passive monitoring
Time frame: 1 year
Proportion of patients in which a flare can be detected based on food purchase data
Time frame: 1 year
Proportion of patients in which a biomarker flare can be detected based on food purchase data
Time frame: 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
Time frame: 1 year
- Interval between onset of a flare and detection based on passive monitoring data
exploratory outcome
Time frame: 1 year
- Subgroup analysis based on the food frequency questionnaire
Exploratory outcome
Time frame: 1 year
- Patient satisfaction based on patient experience questionnaire
Exploratory outcome
Time frame: 1 year
- Proportion of patients in which (different levels of) disability can be detected based on passive monitoring data
.exploratory outcome
Time frame: 1 year
- Proportion of patients in which a change of IBD medication can be detected based on passive monitoring data
Exploratory outcome
Time frame: 1 year
Plan to share: No
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Imelda GI Clinical Research Center