Observing the safety and effectiveness of treatments for children with inflammatory bowel disease

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 aims to analyze the effectiveness and safety of current treatment strategies for pediatric-onset inflammatory bowel disease (IBD) in children under 18 years old. It will include newly diagnosed patients and correlate treatment outcomes with individual risk factors. Additionally, a safety registry will be established to monitor rare and severe complications associated with IBD, providing valuable insights into disease characteristics and treatment responses. The study will gather comprehensive data from various diagnostic procedures to ensure robust findings.

Why it matters

Who can join: the full rules

Inclusion Criteria Inception cohort:

Newly diagnosed patient, \<18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria:

* Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1)
* Diagnosis has been made or is confirmed within 2 months of inclusion
* Data on all diagnostic procedures are available for inclusion in the database
* Informed consent of patient (if indicated) and parents has been obtained
* Concerning the patients of whom biological specimens will be included: patients have not started IBD treatment yet

Inclusion Criteria Safety Registry:

Any child with IBD \<19 years old with complications as detailed in the agreed safety monitoring list (or future updates of the list of conditions) can be reported. For the initial reporting of incident cases no patient identifiable details will be required.

Exclusion Criteria Inception cohort:

* Inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study)
* Informed consent of patient or parents has not been obtained when required
* Patients on similar treatments as for IBD but for other conditions, or known with conditions directly affecting the IBD (e.g. immunodeficiency or major gastrointestinal resections)

Exclusion Criteria Safety registry: none.

Where it's running

• Erasmus MC - Sophia Children's Hospital
  Rotterdam, Netherlands Recruiting
• Royal Hospital London
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Lissy de Ridder, Professor, MD — Erasmus Medical Center
• Study coordinator: Lissy de Ridder, Professor, MD
• Email: l.deridder@erasmusmc.nl
• Phone: +31715262824

Similar studies

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

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• How nutrition and body composition relate to outcomes in people with IBD

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• Research on gut inflammation in pediatric patients with inflammatory bowel diseases

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• Switching to subcutaneous infliximab for IBD treatment

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  Recruiting at 14 sites Phase 4 Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW · Ghent, Oost-Vlaanderen and 14 other locations · NCT06113913

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.