Observing the safety and effectiveness of treatments for children with inflammatory bowel disease

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

This study looks at how safe and effective current treatments are for children under 18 with inflammatory bowel disease to help understand their outcomes and any risks involved.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 0 Years to 19 Years
• Sex: All
• Sponsor: PIBD-Net (Academic / other)
• Locations: 2 sites (Rotterdam and 1 other locations)
• Trial ID: NCT03571373 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze the effectiveness and safety of current treatment strategies for pediatric-onset inflammatory bowel disease (IBD) in children under 18 years old. It will include newly diagnosed patients and correlate treatment outcomes with individual risk factors. Additionally, a safety registry will be established to monitor rare and severe complications associated with IBD, providing valuable insights into disease characteristics and treatment responses. The study will gather comprehensive data from various diagnostic procedures to ensure robust findings.

Who should consider this trial

Good fit: Ideal candidates are children under 18 years old who have recently been diagnosed with inflammatory bowel disease.

Not a fit: Patients who have already started treatment for inflammatory bowel disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies and safety monitoring for children with inflammatory bowel disease.

How similar studies have performed: Other studies have shown success in monitoring treatment outcomes in pediatric IBD, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria Inception cohort:

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

Inclusion Criteria Safety Registry:

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 Criteria Inception cohort:

* 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)

Exclusion Criteria Safety registry: none.

Where this trial is running

Rotterdam and 1 other locations

• Erasmus MC - Sophia Children's Hospital — Rotterdam, Netherlands (Recruiting)
• Royal Hospital London — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Lissy de Ridder, MD, PhD — Erasmus Medical Center
• Study coordinator: Frank Ruemmele, MD, PhD

Conditions Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis