A cohort of patients with Inflammatory Bowel Disease undergoing treatment changes
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
This study is looking to see how treatment changes affect people with Inflammatory Bowel Disease over time to help create more personalized care plans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Luxembourg Institute of Health Government |
| Locations | 1 site (Luxembourg) |
| Trial ID | NCT05733702 on ClinicalTrials.gov |
What this trial studies
This observational study, part of the Clinnova program, aims to recruit at least 800 patients with Inflammatory Bowel Disease (IBD) across France, Germany, and Luxembourg, focusing on those experiencing a significant treatment change. The study will collect a variety of data, including clinical, epidemiological, and omics data, to identify predictive biomarkers for treatment response and disease progression. Participants will be monitored for up to five years, with data collected at multiple time points, including demographics, lifestyle, and patient-reported outcomes. The goal is to enhance personalized treatment approaches through data science and artificial intelligence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with Crohn's disease or ulcerative colitis who are experiencing a significant change in their treatment.
Not a fit: Patients with conditions that hinder compliance with the study protocol or those not experiencing a treatment change may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with Inflammatory Bowel Disease.
How similar studies have performed: Other studies utilizing data science and AI for personalized medicine in IBD have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Luxembourg
- Centre Hospitalier de Luxembourg (CHL) — Luxembourg, Luxembourg (Recruiting)
Study contacts
- Study coordinator: Jasmin Schulz, PhD
- Email: Jasmin.Schulz@lih.lu
- Phone: +352 26970-265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.