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.

Vavricka, Stephan; Ruiz, Pedro A; Scharl, Sylvie; Biedermann, Luc; Scharl, Michael; de Vallière, Cheryl; Lundby, Carsten; Wenger, Roland H; Held, Leonhard; Merz, Tobias; Gassmann, Max; Lutz, Thomas; Kunz, Andres; Bron, Denis; Fontana, Adriano; Strauss, Laura; Weber, Achim; Fried, Michael; Rogler, Gerhard and Zeitz, Jonas (2017). 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. BMJ open, 7(1), e013477. BMJ Publishing Group 10.1136/bmjopen-2016-013477

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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.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care

UniBE Contributor:

Merz, Tobias

Subjects:

600 Technology > 610 Medicine & health

ISSN:

2044-6055

Publisher:

BMJ Publishing Group

Language:

English

Submitter:

Mirella Aeberhard

Date Deposited:

12 Oct 2017 09:39

Last Modified:

12 Oct 2017 09:39

Publisher DOI:

10.1136/bmjopen-2016-013477

PubMed ID:

28057654

Uncontrolled Keywords:

Crohn's disease Hypoxia Ulcerative colitis

BORIS DOI:

10.7892/boris.101312

URI:

https://boris.unibe.ch/id/eprint/101312

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