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Protocol for a prospective, controlled, observational study to evaluate the influence of hypoxia on healthy volunteers and patients with inflammatory bowel disease: the Altitude IBD Study

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dc.contributor.author Vavricka, Stephan
dc.contributor.author Ruiz, Pedro A.
dc.contributor.author Scharl, Sylvie
dc.contributor.author Biedermann, Luc
dc.contributor.author Scharl, Michael
dc.contributor.author de Valliere, Cheryl
dc.contributor.author Lundby, Carsten
dc.contributor.author Wenger, Roland H.
dc.contributor.author Held, Leonhard
dc.contributor.author Merz, Tobias M.
dc.contributor.author Gassmann, Max
dc.contributor.author Lutz, Thomas
dc.contributor.author Kunz, Andres
dc.contributor.author Bron, Denis
dc.contributor.author Fontana, Adriano
dc.contributor.author Strauss, Laura
dc.contributor.author Weber, Achim
dc.contributor.author Fried, Michael
dc.contributor.author Rogler, Gerhard
dc.contributor.author Zeitz, Jonas
dc.date.accessioned 2019-01-25T17:00:27Z
dc.date.available 2019-01-25T17:00:27Z
dc.date.issued 2017
dc.identifier.uri http://doi.org/10.1136/bmjopen-2016-013477
dc.identifier.uri http://repositorio.upch.edu.pe/handle/upch/4943
dc.description.abstract INTRODUCTION: Inflammatory bowel disease (IBD) is a chronic intestinal disorder, often leading to an impaired quality of life in affected patients. The importance of environmental factors in the pathogenesis of IBD, including their disease-modifying potential, is increasingly recognised. Hypoxia seems to be an important driver of inflammation, as has been reported by our group and others. The aim of the study is to evaluate if hypoxia can alter disease activity of IBD measured by Harvey-Bradshaw Activity Index in Crohn's disease (increase to >/=5 points) and the partial Mayo Score for ulcerative colitis (increase to >/=2 points). To test the effects of hypoxia under standardised conditions, we designed a prospective and controlled investigation in healthy controls and patients with IBD in stable remission. METHODS AND ANALYSIS: This is a prospective, controlled and observational study. Participants undergo a 3-hour exposure to hypoxic conditions simulating an altitude of 4000 metres above sea level (m.a.s.l.) in a hypobaric pressure chamber. Clinical parameters, as well as blood and stool samples and biopsies from the sigmoid colon are collected at subsequent time points. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Kanton Zurich (reference KEK-ZH-number 2013-0284). The results will be published in a peer-reviewed journal and shared with the worldwide medical community. TRIALS REGISTRATION NUMBER: NCT02849821; Pre-results.
dc.language.iso eng
dc.publisher BMJ Publishing Group
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Adolescent
dc.subject Adult
dc.subject Humans
dc.subject Young Adult
dc.subject Middle Aged
dc.subject Prospective Studies
dc.subject Biopsy
dc.subject Blood Pressure
dc.subject Research Design
dc.subject Altitude
dc.subject Severity of Illness Index
dc.subject Healthy Volunteers
dc.subject Organ Size
dc.subject Sigmoidoscopy
dc.subject Hypoxia
dc.subject Crohn's disease
dc.subject Ulcerative colitis
dc.subject Angiotensins/blood/urine
dc.subject Colitis, Ulcerative/complications/pathology/physiopathology
dc.subject Colon, Sigmoid/pathology
dc.subject Crohn Disease/complications/pathology/physiopathology
dc.subject Cytokines/metabolism
dc.subject Feces/chemistry
dc.subject Hypoxia-Inducible Factor 1/genetics/metabolism
dc.subject Hypoxia/complications/physiopathology
dc.subject Leukocyte L1 Antigen Complex/analysis
dc.subject Urinary Bladder/anatomy & histology
dc.subject Vasopressins/blood/urine
dc.title Protocol for a prospective, controlled, observational study to evaluate the influence of hypoxia on healthy volunteers and patients with inflammatory bowel disease: the Altitude IBD Study
dc.type info:eu-repo/semantics/article
dc.identifier.journal BMJ Open


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