Clinnova-IBD, a Prospective Cohort of Patients With Inflammatory Bowel Disease (IBD)

Recruiting now

Conditions studied: Inflammatory Bowel Diseases

In brief

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. At least 800 participants (recruited in France, Germany and Luxembourg) will be enrolled, of which 100 participants are expected to be recruited in Luxembourg with the present study protocol. The mission of Clinnova is to support the digitalization of healthcare and precision medicine by creating a data-enabling environment for accessing, sharing and analyzing interoperable, high-quality health data. The main hypothesis is that treatment change decided by clinicians is predictable using objective surrogate markers derived from clinical, epidemiological, and omics data. Identifying these objective markers may facilitate future treatment decisions, provide new insights on the molecular causes for differential treatment response, pathogenesis and progression, and potential pointers for improved personalized therapeutic interventions.

Key facts

Study ID

NCT05733702

Run by

Luxembourg Institute of Health

People needed

100

Starts

2024-02-01

Expected to finish

2029-11-01

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Centre Hospitalier de Luxembourg (CHL) — Luxembourg, Luxembourg (enrolling)

Full record on ClinicalTrials.gov

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