PIBD-SETQuality: the Inception Cohort and Safety Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-19
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- No intervention
Treatment groups
No treatment groups listed
Sponsors and collaborators
Erasmus Medical Center
Lead sponsor
European Commission
Collaborator
Queen Mary University of London
Collaborator
Hôpital Necker-Enfants Malades, Paris
Collaborator
Source ClinicalTrials.gov