Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Brief 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.
Interventions
OTHERNo intervention
No intervention due to the observational set-up of this study.
Sponsors
Erasmus Medical Center
European Commission
Queen Mary University of London
Hôpital Necker-Enfants Malades, Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 19 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictors for outcome and treatment response or non-response | Over a period of three years after inclusion of the last patient. | Factors predictive for outcome and treatment response or non-response This includes factors at baseline and 12 weeks after disease-onset that predict adverse outcomes (e.g. fibrostricturing disease, penetrating disease, active perianal fistula or abcess and need of surgery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New biomarkers as classifiers of response or non-response to therapy | Over a period of three years after inclusion of the last patient. | Part of the children in the inception cohort will deliver biological specimens to develop new biomarkers as classifiers of disease risk of complicated disease or side effects in PIBD patients, as well as predictors of (non-)response to a specific immunomodulator or biological agent. |
| Identification of patients with rare and serious complications | Until the end of patients recruitment, for a period of 2 years. | Secondary outcome is to identify patients with rare and serious complications of PIBD or its treatment. |
Countries
Netherlands, United Kingdom
Contacts
CONTACTLissy de Ridder, Professor, MD
CONTACTNick M. Croft, Professor, MD
PRINCIPAL_INVESTIGATORLissy de Ridder, Professor, MD
Erasmus Medical Center
PRINCIPAL_INVESTIGATORNicholas Croft, Professor, MD
Barts and the London School of Medicine, Queen Mary University of London
PRINCIPAL_INVESTIGATORFrank Ruemmele, Professor, MD
Hopital Necker-Enfants Malades, Paris
Outcome results
None listed