RecruitingNCT03571373

PIBD-SETQuality: the Inception Cohort and Safety Registry

Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality Improvement of Care: The PIBD-NET Inception Cohort and Safety Registry

Sponsor

PIBD-Net

Enrollment

1,500 participants

Start Date

Jan 3, 2017

Study Type

OBSERVATIONAL

Conditions

Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

Summary

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

Min Age: 0 YearsMax Age: 19 Years

Inclusion Criteria7

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 Criteria3

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)