International prospective observational study investigating the disease course and heterogeneity of paediatric-onset inflammatory bowel disease: the protocol of the PIBD-SETQuality inception cohort study
Sibylle Koletzko,
Richard K Russell,
Arie Levine,
Dan Turner,
Lissy de Ridder,
Frank M Ruemmele,
Martine A Aardoom,
Janneke N Samsom,
Nicholas M Croft,
Marina Aloi,
Gigi Veereman,
Mattias Neyt,
Polychronis Kemos,
Irma Tindemans,
Thomas D Walters
Affiliations
Sibylle Koletzko
Department of Pediatrics, Gastroenterology and Nutrition, University of Warmia and Mazury in Olsztyn School of Medicine, Olsztyn, Poland
Richard K Russell
Department of Paediatric Gastroenterology, Hepatology and Nutrition, Royal Hospital for Children Glasgow, Glasgow, UK
Arie Levine
Paediatric Gastroenterology and Nutrition Unit, Edith Wolfson Medical Center, Tel Aviv University, Holon, Israel
Dan Turner
6 The Juliet Keidan Institute of Pediatric Gastroenterology and Nutrition, The Hebrew University of Jerusalem, Shaare Zedek Medical Center, Jerusalem, Israel
Lissy de Ridder
9 Department of Paediatric Gastroenterology, Sophia Children’s Hospital/ Erasmus MC University, Rotterdam, The Netherlands
Frank M Ruemmele
Department of Paediatric Gastroenterology, Université Paris Descartes, Paris, Île-de-France, France
Martine A Aardoom
Department of Paediatric Gastroenterology, Erasmus University Medical Center-Sophia Children`s Hospital, Rotterdam, The Netherlands
Janneke N Samsom
Laboratory of Pediatrics, Division of Gastroenterology and Nutrition, Erasmus University Medical Center-Sophia Children`s Hospital, Rotterdam, The Netherlands
Nicholas M Croft
Centre for Immunobiology, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Marina Aloi
Paediatric Gastroenterology and Liver Unit, Department of Paediatrics, Sapienza University of Rome, Rome, Italy
Gigi Veereman
Free University Brussels, University Hospital, Brussels, Belgium
Mattias Neyt
senior researcher
Polychronis Kemos
Centre for Immunobiology, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Irma Tindemans
Laboratory of Pediatrics, Division of Gastroenterology and Nutrition, Erasmus University Medical Center-Sophia Children`s Hospital, Rotterdam, The Netherlands
Thomas D Walters
IBD Centre, Department of Paediatrics, SickKids Hospital, University of Toronto, Toronto, Ontario, Canada
Introduction Patients with paediatric-onset inflammatory bowel disease (PIBD) may develop a complicated disease course, including growth failure, bowel resection at young age and treatment-related adverse events, all of which can have significant and lasting effects on the patient’s development and quality of life. Unfortunately, we are still not able to fully explain the heterogeneity between patients and their disease course and predict which patients will respond to certain therapies or are most at risk of developing a more complicated disease course. To investigate this, large prospective studies with long-term follow-up are needed. Currently, no such European or Asian international cohorts exist. In this international cohort, we aim to evaluate disease course and which patients are most at risk of therapy non-response or development of complicated disease based on patient and disease characteristics, immune pathology and environmental and socioeconomic factors.Methods and analysis In this international prospective observational study, which is part of the PIBD Network for Safety, Efficacy, Treatment and Quality improvement of care (PIBD-SETQuality), children diagnosed with inflammatory bowel disease <18 years are included at diagnosis. The follow-up schedule is in line with standard PIBD care and is intended to continue up to 20 years. Patient and disease characteristics, as well as results of investigations, are collected at baseline and during follow-up. In addition, environmental factors are being assessed (eg, parent’s smoking behaviour, dietary factors and antibiotic use). In specific centres with the ability to perform extensive immunological analyses, blood samples and intestinal biopsies are being collected and analysed (flow cytometry, plasma proteomics, mRNA expression and immunohistochemistry) in therapy-naïve patients and during follow-up.Ethics and dissemination Medical ethical approval has been obtained prior to patient recruitment for all sites. The results will be disseminated through peer-reviewed scientific publications.Trial registration number NCT03571373.
