NCT03571373

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: PIBD-Net · Academic / Other
• Sex: All
• Age: 0 Years – 19 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Inflammatory Bowel Diseases
• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	No intervention	No intervention due to the observational set-up of this study.

Timeline

• Start date: 2017-01-03
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2018-06-27
• Last updated: 2025-08-01

Locations

2 sites across 2 countries: Netherlands, United Kingdom