๐ฌIn plain words
What the trial is, and whether it could suit you
The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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.
Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands
Royal Hospital London
London, United Kingdom
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.