A cohort of patients with Inflammatory Bowel Disease undergoing treatment changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier de Luxembourg (CHL)
  Luxembourg, Luxembourg Recruiting

Study contacts

• Study coordinator: Jasmin Schulz, PhD
• Email: Jasmin.Schulz@lih.lu
• Phone: +352 26970-265

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-Term Guselkumab Use in Adults with Inflammatory Bowel Disease

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• Resting energy use in kids with inflammatory bowel disease

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• Active video education by disease subtype to improve bowel prep before colonoscopy

  We’re testing whether adding subtype-specific video education to standard prep improves bowel cleanliness in adults with IBD undergoing colonoscopy.

  Recruiting at 12 sites Xijing Hospital of Digestive Diseases · Beijing, BeijingBeijing and 11 other locations · NCT07582731

• Intestinal ultrasound to predict relapse in Crohn's disease patients in deep remission.

  This project will try to see if a noninvasive transabdominal ultrasound can predict relapses in adults with Crohn's disease who are currently in deep remission.

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• Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics

  This study tests ATH-063 to see if it helps people with moderate to severe ulcerative colitis who did not respond to or relapsed after prior biologic therapy.

  Recruiting at 4 sites Phase 2 Athos Therapeutics Inc · Miami, Florida and 3 other locations · NCT07513181

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.