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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

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...

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Autores principales: Aardoom, Martine A, Kemos, Polychronis, Tindemans, Irma, Aloi, Marina, Koletzko, Sibylle, Levine, Arie, Turner, Dan, Veereman, Gigi, Neyt, Mattias, Russell, Richard K, Walters, Thomas D, Ruemmele, Frank M, Samsom, Janneke N, Croft, Nicholas M, de Ridder, Lissy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7332186/
https://www.ncbi.nlm.nih.gov/pubmed/32611739
http://dx.doi.org/10.1136/bmjopen-2019-035538
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author Aardoom, Martine A
Kemos, Polychronis
Tindemans, Irma
Aloi, Marina
Koletzko, Sibylle
Levine, Arie
Turner, Dan
Veereman, Gigi
Neyt, Mattias
Russell, Richard K
Walters, Thomas D
Ruemmele, Frank M
Samsom, Janneke N
Croft, Nicholas M
de Ridder, Lissy
author_facet Aardoom, Martine A
Kemos, Polychronis
Tindemans, Irma
Aloi, Marina
Koletzko, Sibylle
Levine, Arie
Turner, Dan
Veereman, Gigi
Neyt, Mattias
Russell, Richard K
Walters, Thomas D
Ruemmele, Frank M
Samsom, Janneke N
Croft, Nicholas M
de Ridder, Lissy
author_sort Aardoom, Martine A
collection PubMed
description 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.
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spelling pubmed-73321862020-07-07 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 Aardoom, Martine A Kemos, Polychronis Tindemans, Irma Aloi, Marina Koletzko, Sibylle Levine, Arie Turner, Dan Veereman, Gigi Neyt, Mattias Russell, Richard K Walters, Thomas D Ruemmele, Frank M Samsom, Janneke N Croft, Nicholas M de Ridder, Lissy BMJ Open Gastroenterology and Hepatology 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. BMJ Publishing Group 2020-07-01 /pmc/articles/PMC7332186/ /pubmed/32611739 http://dx.doi.org/10.1136/bmjopen-2019-035538 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Gastroenterology and Hepatology
Aardoom, Martine A
Kemos, Polychronis
Tindemans, Irma
Aloi, Marina
Koletzko, Sibylle
Levine, Arie
Turner, Dan
Veereman, Gigi
Neyt, Mattias
Russell, Richard K
Walters, Thomas D
Ruemmele, Frank M
Samsom, Janneke N
Croft, Nicholas M
de Ridder, Lissy
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Gastroenterology and Hepatology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7332186/
https://www.ncbi.nlm.nih.gov/pubmed/32611739
http://dx.doi.org/10.1136/bmjopen-2019-035538
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