NCT05733702 Clinnova-IBD, a Prospective Cohort of Patients With Inflammatory Bowel Disease (IBD)
| NCT ID | NCT05733702 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luxembourg Institute of Health |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-02-01 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05733702 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05733702 currently recruiting?
Yes, NCT05733702 is actively recruiting participants. Contact the research team at Jasmin.Schulz@lih.lu for enrollment information.
Where is the NCT05733702 trial being conducted?
This trial is being conducted at Luxembourg, Luxembourg.
Who is sponsoring the NCT05733702 clinical trial?
NCT05733702 is sponsored by Luxembourg Institute of Health. The trial plans to enroll 100 participants.