Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
Observational · No treatment assigned · 3 sites · Maastricht University Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC) and Crohn Disease (CD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 18 years or older
- Crohn's Disease or ulcerative colitis
- Having a smartwatch and/or a smartphone
- Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available)
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 600 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-08-04.
- Main results expected around 2027-12-15 (estimate from the record).
- 3 study sites listed (2 marked recruiting) in Netherlands.
Groups in this study
- Patients with IBD
Main thing being measured
- Prediction of mucosal inflammation (calprotectin≥250 µg/g and/or CRP≥5mg/l with UCEIS≥1 or Mayo≥1 (UC) and SES CD≥3 (CD) on endoscopic/radiological evaluation) using HRV-changes relative to… (1 year)
In the researchers’ words
The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.
Words you might see
- Fecal calprotectin: a stool test that measures inflammation in the gut.
- Endoscopy: a camera exam inside the digestive tract.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn Disease (CD) |
| Lead sponsor | Maastricht University Medical Center |
| Collaborators | Maastricht University; TNO; Franciscus Gasthuis & Vlietland (Hospital); Jeroen Bosch Ziekenhuis, s'-Hertogenbosch |
| Enrollment | 600 (estimated) |
| Start date | 2026-08-04 |
| Primary completion (est.) | 2027-12-15 |
| First posted | 2026-06-15 |
| Last updated | 2026-10-13 |
| Official title | Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study |
| ClinicalTrials.gov ID | NCT07647640 |
Interventions
- Wearing their own wearable device. (Device)
Wearing their own wearable device.
Full eligibility criteria (from the record)
Inclusion Criteria: * 18 years or older * Crohn's Disease or ulcerative colitis * Having a smartwatch and/or a smartphone * Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available) Exclusion Criteria: * No specific exclusion criteria will be used. Subgroup analysis will be performed for patients with e.g. heart problems or arrhythmia, medication impacting HR (such as beta blockers), pregnancy, thyroid problems, shift work...
Locations (3)
| Site | City | Country | Site status |
|---|---|---|---|
| Jeroen Bosch Hospital | 's-Hertogenbosch | Netherlands | Recruiting |
| Maastricht UMC+ | Maastricht | Netherlands | Recruiting |
| Franciscus Hospital | Rotterdam | Netherlands | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.