The Altitude Inflammatory Bowel Disease Study

Summary

This is a prospective, controlled and observational study. Participants underwent a 3-hour exposure to hypoxic conditions simulating an altitude of 4,000 meters 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 (by sigmoidoscopy) are collected at subsequent time points. The investigators goal is to evaluate if a 3-hour stay at high altitude (4, 000 m) can alter disease activity and can modulate a pro inflammatory reaction.

Conditions

• Inflammatory Bowel Disease

Interventions

OTHER

hypobaric pressure chamber

hypobaric chamber: ascent within 10 minutes, 3 hour exposure to hypoxic conditions simulating an altitude of 4,000 m.a.s.l., afterwards controlled descent under continuous pulsoximetric control

OTHER

Sigmoidoscopy

To retrieve biopsies from the colon during the course of the study 3 sigmoidoscopies were performed. The first sigmoidoscopy was performed 1 day before the stay in the hypobaric chamber. The second sigmoidoscopy was performed directly after the hypobaric chamber and the third sigmoidoscopy was performed 1 week after the hypobaric chamber. During each sigmoidoscopy 6 biopsies were taken with standard size forceps (2.4 mm). One biopsy was analysed by real-time quantitative polymerase chain reaction (PCR), one biopsy was analysed by Western blotting and another biopsy was analysed for gene gene-expression by in situ hybridisation. Two biopsies were analysed by immunohistochemistry (IHC) and one biopsy was stained with hematoxylin and eosin (H\&E).

Sponsors & Collaborators

• Triemli Hospital

  collaborator OTHER

• Zurich Center for Integrative Human Physiology

  collaborator OTHER

• Institute of Biostatistics

  collaborator UNKNOWN

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Institute of Physiology Irchel

  collaborator UNKNOWN

• Institute of Veterinary Physiology

  collaborator UNKNOWN

• Swiss Aeromedical Center Switzerland

  collaborator UNKNOWN

• Institute of Experimental Immunology

  collaborator UNKNOWN

• University Hospital, Zürich

  collaborator OTHER

• University of Zurich

  lead OTHER

Principal Investigators

• Stephan R Vavricka, Prof. Dr. · University of Zurich

Study Design

Allocation

NA

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2015-09-30

Completion

2016-12-31