Overview
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.
Description
In this prospective observational study children with newly diagnosed inflammatory bowel disease (IBD) will be included in the inception cohort. The primary aim of the inception cohort is to analyse the effectiveness and safety signals of current treatment strategies and to correlate them to individual risk factors. In order to capture information on rare and severe complications in PIBD as well, the safety registry was designed to estimate incidence and prevalence rates of these complications and get more insight in disease and treatment characteristics of these patients.
Eligibility
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.