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| BMJ open. 2022 Jun 27. pii: bmjopen-2021-055779. doi: 10.1136/bmjopen-2021-055779 |
| 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. |
| Attauabi M1, Madsen GR2, Bendtsen F3, Wewer AV4, Wilkens R5, Ilvemark J6, Vladimirova N7, Jensen AB8, Jensen FK9, Hansen SB10, Siebner HR11, Nielsen YJW12, Møller JM13, Thomsen HS14, Thomsen SF15, Ingels HAS16, Theede K17, Boysen T18, Bjerrum JT19, Jakobsen C20, Dorn-Rasmussen M21, Jansson S22, Yao Y23, Burian EA24, Møller FT25, Fana V26, Wiell C27, Terslev L28, Østergaard M29, Bertl K30, Stavropoulos A31, Seidelin JB32, Burisch J33 |
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Abstract 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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© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
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KEYWORDS: Adult gastroenterology, EPIDEMIOLOGY, IMMUNOLOGY, Inflammatory bowel disease, MOLECULAR BIOLOGY, Paediatric gastroenterology |
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Publikations ID: 35760545 Quelle: öffnen |
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