IBD (general)Recruiting
Clinnova-IBD, a Prospective Cohort of Patients With Inflammatory Bowel Disease (IBD)
Observational · No treatment assigned · 1 site · Luxembourg Institute of Health
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases. 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 old
- Participants are willing and able to comply with the protocol including undergoing data and sample collection as well as study visits and examinations.
- Signed informed consent form
Plus 1 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2024-02-01.
- Main results expected around 2029-11 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Luxembourg.
Main thing being measured
- Identify clinical, epidemiological and omics characteristics associated with IBD activity triggering a treatment change in patients with UC or CD and allow the phenotyping of patients with similar… (2029)
In the researchers’ words
This study is part of the Clinnova program. This is a prospective cohort study including patients with IBD recruited at the time of a treatment change.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
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 Diseases |
| Lead sponsor | Luxembourg Institute of Health |
| Collaborators | Luxembourg National Research Fund; Centre Hospitalier du Luxembourg; Hôpitaux Robert Schuman; University of Luxembourg |
| Enrollment | 100 (estimated) |
| Start date | 2024-02-01 |
| Primary completion (est.) | 2029-11 |
| First posted | 2023-02-17 |
| Last updated | 2025-09-22 |
| Official title | A Prospective Cohort Study of Patients With Inflammatory Bowel Disease: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care |
| ClinicalTrials.gov ID | NCT05733702 |
Interventions
- All participants will be asked to provide data and samples for collection and analysis. (Other)
During the first year from the date of inclusion, data related to demographics, lifestyle, laboratory and physical examinations will be collected at baseline, at 3 months, and at 12 months. Patient-Reported Outcomes (PROs) with voice recordings will be collected at different time points in-between clinical visits using the Colive application. Participants will be asked to provide biological sample…
Full eligibility criteria (from the record)
Inclusion Criteria: * ≥ 18 years old * Participants are willing and able to comply with the protocol including undergoing data and sample collection as well as study visits and examinations. * Signed informed consent form * Diagnosed with Inflammatory bowel disease, either Crohn's disease or ulcerative colitis, at least 3 months before the enrolment AND occurrence of a significant change in the treatment of the disease (either change of drug dosage OR change of medication within the same treatment class OR change of treatment class OR addition of a drug to a treatment regimen already ongoing). A change of drug dosage or frequency is considered significant if it fulfills the requirements in section 7.1 Note: Patients with ostomy or with short bowel syndrome can be included if they fulfill all the eligibility criteria Exclusion Criteria: * Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits (such as mental disability that makes it difficult or impossible to answer questionnaires) * Not fluent in any of the following languages: French, English or German * Known pregnancy
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de Luxembourg (CHL) | Luxembourg | Luxembourg | 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.