Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort Study

Introduction Inflammatory bowel diseases (IBD), encompassing Crohn’s disease and ulcerative colitis, are chronic, inflammatory diseases of the gastrointestinal tract. We have initiated a Danish population-based inception cohort study aiming to investigate the underlying mechanisms for the heterogene...

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Main Authors: Johan Burisch, Lene Terslev, Mikkel Østergaard, Annette Bøjer Jensen, Frank Krieger Jensen, Flemming Bendtsen, Charlotte Wiell, Mohamed Attauabi, Klaus Theede, Viktoria Fana, Hartwig Roman Siebner, Henrik S Thomsen, Jakob M Møller, Simon Francis Thomsen, Gorm Roager Madsen, Anne Vibeke Wewer, Rune Wilkens, Johan Ilvemark, Nora Vladimirova, Sanja Bay Hansen, Yousef Jesper Wirenfeldt Nielsen, Helene Andrea Sinclair Ingels, Trine Boysen, Jacob T Bjerrum, Christian Jakobsen, Maria Dorn-Rasmussen, Sabine Jansson, Yiqiu Yao, Ewa Anna Burian, Frederik Trier Møller, Kristina Bertl, Andreas Stavropoulos, Jakob B Seidelin
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Language:English
Published: BMJ Publishing Group 2022-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/6/e055779.full
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author Johan Burisch
Lene Terslev
Mikkel Østergaard
Annette Bøjer Jensen
Frank Krieger Jensen
Flemming Bendtsen
Charlotte Wiell
Mohamed Attauabi
Klaus Theede
Viktoria Fana
Hartwig Roman Siebner
Henrik S Thomsen
Jakob M Møller
Simon Francis Thomsen
Gorm Roager Madsen
Anne Vibeke Wewer
Rune Wilkens
Johan Ilvemark
Nora Vladimirova
Sanja Bay Hansen
Yousef Jesper Wirenfeldt Nielsen
Helene Andrea Sinclair Ingels
Trine Boysen
Jacob T Bjerrum
Christian Jakobsen
Maria Dorn-Rasmussen
Sabine Jansson
Yiqiu Yao
Ewa Anna Burian
Frederik Trier Møller
Kristina Bertl
Andreas Stavropoulos
Jakob B Seidelin
author_facet Johan Burisch
Lene Terslev
Mikkel Østergaard
Annette Bøjer Jensen
Frank Krieger Jensen
Flemming Bendtsen
Charlotte Wiell
Mohamed Attauabi
Klaus Theede
Viktoria Fana
Hartwig Roman Siebner
Henrik S Thomsen
Jakob M Møller
Simon Francis Thomsen
Gorm Roager Madsen
Anne Vibeke Wewer
Rune Wilkens
Johan Ilvemark
Nora Vladimirova
Sanja Bay Hansen
Yousef Jesper Wirenfeldt Nielsen
Helene Andrea Sinclair Ingels
Trine Boysen
Jacob T Bjerrum
Christian Jakobsen
Maria Dorn-Rasmussen
Sabine Jansson
Yiqiu Yao
Ewa Anna Burian
Frederik Trier Møller
Kristina Bertl
Andreas Stavropoulos
Jakob B Seidelin
author_sort Johan Burisch
collection DOAJ
description Introduction Inflammatory bowel diseases (IBD), encompassing Crohn’s disease and ulcerative colitis, are chronic, inflammatory diseases of the gastrointestinal tract. We have initiated a Danish population-based inception cohort study aiming to investigate the underlying mechanisms for the heterogeneous course of IBD, including need for, and response to, treatment.Methods and analysis IBD Prognosis Study is a prospective, population-based inception cohort study of unselected, newly diagnosed adult, adolescent and paediatric patients with IBD within the uptake area of Hvidovre University Hospital and Herlev University Hospital, Denmark, which covers approximately 1 050 000 inhabitants (~20% of the Danish population). The diagnosis of IBD will be according to the Porto diagnostic criteria in paediatric and adolescent patients or the Copenhagen diagnostic criteria in adult patients. All patients will be followed prospectively with regular clinical examinations including ileocolonoscopies, MRI of the small intestine, validated patient-reported measures and objective examinations with intestinal ultrasound. In addition, intestinal biopsies from ileocolonoscopies, stool, rectal swabs, saliva samples, swabs of the oral cavity and blood samples will be collected systematically for the analysis of biomarkers, microbiome and genetic profiles. Environmental factors and quality of life will be assessed using questionnaires and, when available, automatic registration of purchase data. The occurrence and course of extraintestinal manifestations will be evaluated by rheumatologists, dermatologists and dentists, and assessed by MR cholangiopancreatography, MR of the spine and sacroiliac joints, ultrasonography of peripheral joints and entheses, clinical oral examination, as well as panoramic radiograph of the jaws. Fibroscans and dual-energy X-ray absorptiometry scans will be performed to monitor occurrence and course of chronic liver diseases, osteopenia and osteoporosis.Ethics and dissemination This study has been approved by Ethics Committee of the Capital Region of Denmark (approval number: H-20065831). Study results will be disseminated through publication in international scientific journals and presentation at (inter)national conferences.
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spelling doaj-art-76004068575948ef84d63527915e8b992025-01-24T07:20:13ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-055779Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort StudyJohan Burisch0Lene Terslev1Mikkel Østergaard2Annette Bøjer Jensen3Frank Krieger Jensen4Flemming Bendtsen5Charlotte Wiell6Mohamed Attauabi7Klaus Theede8Viktoria Fana9Hartwig Roman Siebner10Henrik S Thomsen11Jakob M Møller12Simon Francis Thomsen13Gorm Roager Madsen14Anne Vibeke Wewer15Rune Wilkens16Johan Ilvemark17Nora Vladimirova18Sanja Bay Hansen19Yousef Jesper Wirenfeldt Nielsen20Helene Andrea Sinclair Ingels21Trine Boysen22Jacob T Bjerrum23Christian Jakobsen24Maria Dorn-Rasmussen25Sabine Jansson26Yiqiu Yao27Ewa Anna Burian28Frederik Trier Møller29Kristina Bertl30Andreas Stavropoulos31Jakob B Seidelin32Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, Hvidovre, DenmarkCentre for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark2 Department of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark3 Department of Radiology, Hvidovre Hospital, Hvidovre, Denmark3 Department of Radiology, Hvidovre Hospital, Hvidovre, Denmark3 Gastrounit Medical Division, Hvidovre Hospital, Hvidovre, Denmark13 Department of Rheumatology, Gentofte University Hospital, Hellerup, DenmarkDepartment of Gastroenterology and Hepatology, Copenhagen University Hospital—Herlev and Gentofte, Herlev Hospital, Copenhagen, DenmarkCopenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, Hvidovre, DenmarkRigshospitalet-Glostrup, Center for Rheumatology and Spine Diseases, Copenhagen, DenmarkDepartment of Clinical Physiology and Nuclear Medicine, Center for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, DenmarkDepartment of Radiology, Herlev Hospital, Herlev, DenmarkDepartment of Radiology, Herlev Hospital, Herlev, Denmark1 Department of Dermatology, Bispebjerg Hospital, Copenhagen, DenmarkCopenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, Hvidovre, DenmarkCopenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, Hvidovre, DenmarkCopenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, Hvidovre, DenmarkDepartment of Gastroenterology and Hepatology, Herlev Hospital, Herlev, DenmarkCopenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, DenmarkDepartment of Radiology, Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, Hvidovre, DenmarkDepartment of Radiology, Herlev Hospital, Herlev, DenmarkDepartment of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Kobenhavn, DenmarkCopenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, Hvidovre, DenmarkDepartment of Gastroenterology and Hepatology, Herlev Hospital, Herlev, DenmarkCopenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, Hvidovre, DenmarkCopenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, Hvidovre, DenmarkThe Paediatric Department, Hvidovre Hospital, Hvidovre, DenmarkDepartment of Dermatology, Bispebjerg Hospital, Kobenhavn, DenmarkDepartment of Dermatology, Bispebjerg Hospital, Kobenhavn, DenmarkDepartment of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Copenhagen, DenmarkDepartment of Periodontology, Malmö Universitet, Malmo, SwedenMalmo Universitet, Malmo, SwedenDepartment of Gastroenterology and Hepatology, Herlev Hospital, Herlev, DenmarkIntroduction Inflammatory bowel diseases (IBD), encompassing Crohn’s disease and ulcerative colitis, are chronic, inflammatory diseases of the gastrointestinal tract. We have initiated a Danish population-based inception cohort study aiming to investigate the underlying mechanisms for the heterogeneous course of IBD, including need for, and response to, treatment.Methods and analysis IBD Prognosis Study is a prospective, population-based inception cohort study of unselected, newly diagnosed adult, adolescent and paediatric patients with IBD within the uptake area of Hvidovre University Hospital and Herlev University Hospital, Denmark, which covers approximately 1 050 000 inhabitants (~20% of the Danish population). The diagnosis of IBD will be according to the Porto diagnostic criteria in paediatric and adolescent patients or the Copenhagen diagnostic criteria in adult patients. All patients will be followed prospectively with regular clinical examinations including ileocolonoscopies, MRI of the small intestine, validated patient-reported measures and objective examinations with intestinal ultrasound. In addition, intestinal biopsies from ileocolonoscopies, stool, rectal swabs, saliva samples, swabs of the oral cavity and blood samples will be collected systematically for the analysis of biomarkers, microbiome and genetic profiles. Environmental factors and quality of life will be assessed using questionnaires and, when available, automatic registration of purchase data. The occurrence and course of extraintestinal manifestations will be evaluated by rheumatologists, dermatologists and dentists, and assessed by MR cholangiopancreatography, MR of the spine and sacroiliac joints, ultrasonography of peripheral joints and entheses, clinical oral examination, as well as panoramic radiograph of the jaws. Fibroscans and dual-energy X-ray absorptiometry scans will be performed to monitor occurrence and course of chronic liver diseases, osteopenia and osteoporosis.Ethics and dissemination This study has been approved by Ethics Committee of the Capital Region of Denmark (approval number: H-20065831). Study results will be disseminated through publication in international scientific journals and presentation at (inter)national conferences.https://bmjopen.bmj.com/content/12/6/e055779.full
spellingShingle Johan Burisch
Lene Terslev
Mikkel Østergaard
Annette Bøjer Jensen
Frank Krieger Jensen
Flemming Bendtsen
Charlotte Wiell
Mohamed Attauabi
Klaus Theede
Viktoria Fana
Hartwig Roman Siebner
Henrik S Thomsen
Jakob M Møller
Simon Francis Thomsen
Gorm Roager Madsen
Anne Vibeke Wewer
Rune Wilkens
Johan Ilvemark
Nora Vladimirova
Sanja Bay Hansen
Yousef Jesper Wirenfeldt Nielsen
Helene Andrea Sinclair Ingels
Trine Boysen
Jacob T Bjerrum
Christian Jakobsen
Maria Dorn-Rasmussen
Sabine Jansson
Yiqiu Yao
Ewa Anna Burian
Frederik Trier Møller
Kristina Bertl
Andreas Stavropoulos
Jakob B Seidelin
Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort Study
BMJ Open
title Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort Study
title_full Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort Study
title_fullStr Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort Study
title_full_unstemmed Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort Study
title_short Influence of Genetics, Immunity and the Microbiome on the Prognosis of Inflammatory Bowel Disease (IBD Prognosis Study): the protocol for a Copenhagen IBD Inception Cohort Study
title_sort influence of genetics immunity and the microbiome on the prognosis of inflammatory bowel disease ibd prognosis study the protocol for a copenhagen ibd inception cohort study
url https://bmjopen.bmj.com/content/12/6/e055779.full
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