Article Text
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.
- Hypoxia
- Crohn's disease
- Ulcerative colitis
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Statistics from Altmetric.com
Footnotes
Contributors JZ, SV and GR were the initiators of this study. JZ wrote the study protocol. JZ, SV, SS, PAR, DB and LB conducted the study procedures. All other authors took part in data acquisition and study planning. JZ and SV wrote and revised the final manuscript and all authors read and approved it.
Funding This project is mainly supported by a grant from the IBDnet and by an unrestricted study grant from AbbVie (to GR, SV and JZ) and further supported by the NCCR Kidney.CH (to CL, RHW) and the ZIHP (to MG).
Competing interests None declared.
Ethics approval Ethics Committee of the Kanton Zurich, Switzerland (KEK-ZH-Nr. 2013-0284, 30 April 2014).
Provenance and peer review Not commissioned; externally peer reviewed.