Actively Recruiting

Age: 0Years - 19Years
All Genders
Healthy Volunteers
NCT03571373

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

Age: 0Years - 19Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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