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NCT Number: NCT07159776

Multiple Digital Biomarkers for Optimization of IBD Care

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

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Key information

Conditions

Crohn Disease (CD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imelda General Hospital

Bonheiden, 2820, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

monitoring of wearable data, shopping data, biomarkers and patient reported outcomes

Device
  • 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.
  • 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.
  • biomarkers in blood and feaces will be monitored according to standard of care
  • patient reported outcomes will be monitored according to standard of care

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Proportion of patients in which a biomarker flare can be detected based on passive monitoring data

    Time frame: 1 year

  2. 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

  3. Proportion of patients in which a flare can be detected based on food purchase data

    Time frame: 1 year

  4. Proportion of patients in which a biomarker flare can be detected based on food purchase data

    Time frame: 1 year

  5. 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

Other outcomes

  1. - Interval between onset of a flare and detection based on passive monitoring data

    Time frame: 1 year

    exploratory outcome

  2. - Subgroup analysis based on the food frequency questionnaire

    Time frame: 1 year

    Exploratory outcome

  3. - Patient satisfaction based on patient experience questionnaire

    Time frame: 1 year

    Exploratory outcome

  4. - Proportion of patients in which (different levels of) disability can be detected based on passive monitoring data

    Time frame: 1 year

    .exploratory outcome

  5. - Proportion of patients in which a change of IBD medication can be detected based on passive monitoring data

    Time frame: 1 year

    Exploratory outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Lieven Pouillon, MD

CONTACT

Peter Bossuyt, MD PhD

CONTACT

[email protected]

+32 15 50 56 91

Sponsors and collaborators

Lead sponsor

Imelda GI Clinical Research Center

Other

Collaborators

  • Agentschap Innoveren & Ondernemen (VLAIO)

Registry information

Acronym: LEGEND-IBD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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