Actively Recruiting
PIBD-SETQuality: the Inception Cohort and Safety Registry
Led by PIBD-Net · Updated on 2025-08-01
1500
Participants Needed
2
Research Sites
573 weeks
Total Duration
On this page
Sponsors
P
PIBD-Net
Lead Sponsor
E
European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PIBD-SETQuality: the Inception Cohort and Safety Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed patient younger than 18 years with a likely or confirmed diagnosis of inflammatory bowel disease (IBD)
- Diagnosis based on history, physical exam, lab, endoscopy, radiology, and histology according to Porto criteria
- Diagnosis confirmed within 2 months before inclusion
- All diagnostic procedure data available for the database
- Informed consent obtained from patient (if applicable) and parents
- For those providing biological specimens: no IBD treatment started yet
- Any child under 19 years with IBD complications listed in the safety monitoring list can be reported to the safety registry
You will not qualify if you...
- Unable to read and understand patient and family information sheets without help
- Informed consent not obtained when required
- Patients treated for other conditions with similar treatments or with conditions directly affecting IBD (e.g., immunodeficiency or major gastrointestinal surgery)
- No exclusion criteria for the safety registry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands, 3015GD
Actively Recruiting
2
Royal Hospital London
London, United Kingdom
Actively Recruiting
Research Team
F
Frank Ruemmele, MD, PhD
CONTACT
L
Lissy de Ridder, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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