RecruitingNCT05733702

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

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

Sponsor

Luxembourg Institute of Health

Enrollment

100 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

Inflammatory Bowel Diseases

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

Min Age: 18 Years

Inclusion Criteria4

≥ 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 Criteria3

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

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Interventions

OTHERAll participants will be asked to provide data and samples for collection and analysis.

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 samples (i.e., blood, dried blood spots and stool are mandatory; saliva, urine and hair are optional), tissue samples from endoscopic biopsy and imaging data (if performed as per standard of care) at three timepoints (baseline; 3 months; 12 months). One unscheduled visit may be included in the study in case of occurrence of flare or treatment change.A long-term follow-up (starting from month 12 and up to 4 years after month 12) will include the collection of medical data on a yearly basis, collection of PROs with voice recording every 6 months and continuous collection of data using the smartwatch.