Follows children with inflammatory bowel disease to study routine treatment outcomes
Studies how routine treatments work and their safety in young patients with bowel inflammation.
Plain-language title generated from the registry record
Registry title: PIBD-SETQuality: the Inception Cohort and Safety Registry
Key facts
- Where
- London, United KingdomSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 19 years old?
Source: NCT03571373, who can take part
Where in United Kingdom
- Royal Hospital LondonLondon, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Medical Center
- Trial code
- NCT03571373
- Record updated
- 11 August 2026
- Original description
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.Read full original descriptionShow less
Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality Improvement of Care: The PIBD-NET Inception Cohort and Safety Registry
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.
Inclusion: 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; 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: 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); 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.