Clinical trial NCT02849821: The Altitude Inflammatory Bowel Disease Study
Official title: A Study on the Influence of Hypoxia on Healthy Volunteers and Patients With Inflammatory Bowel Disease (IBD): The Altitude IBD Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Triemli Hospital
name: Zurich Center for Integrative Human Physiology
name: Institute of Biostatistics
name: Insel Gruppe AG, University Hospital Bern
name: Institute of Physiology Irchel
name: Institute of Veterinary Physiology
name: Swiss Aeromedical Center Switzerland
name: Institute of Experimental Immunology
name: University Hospital, Zürich
First posted: 2016-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.

Detailed description: To evaluate the potential influence of hypoxia on the course of IBD on a biomolecular level, and to test the effects of hypoxia under standardized conditions, the investigators initiated a prospective and controlled investigation in healthy controls and IBD patients in stable remission. the investigators primary aim is to show that a 3-hour stay at high altitude can alter disease activity of IBD. Ten healthy volunteers, 11 Crohn's disease (CD) patients and 9 ulcerative colitis (UC) patients underwent a 3-hour exposure to hypoxic conditions simulating an altitude of 4,000 m.a.s.l. in a hypobaric low-pressure chamber situated at the Swiss Aeromedical Center, Dubendorf, Switzerland. Stool samples for the analysis of calprotectin and microbiotal composition, biopsy samples from the rectosigmoid region, and blood samples were repetitively collected and analysed in conjunction with detailed records of clinical symptoms over a subsequent interval of 4 weeks.

Eligibility criteria: Inclusion Criteria:

* had a diagnosis of Crohn's disease or ulcerative colitis at least 6 months prior to inclusion
* gave written consent
* were in clinical remission (measured by Harvey Bradshaw Activity Index (HBI) in CD and the partial Mayo Score for UC)

Exclusion Criteria:

* had contraindications for a sigmoidoscopy
* had intercurrent bacterial or viral intestinal disease (by culture or serology)
* were pregnant or breast feeding
* had a severe concomitant disease which excluded from participating in the study by means of the study physician
* were likely to or showed no cooperation for the study procedures
* had active infection or systemic antibiotic, antiviral or antifungal treatment 3 weeks before baseline
* were suffering from short-bowel syndrome
* were receiving parenteral nutrition
* had a clinical condition which did not allow a stay at heights of 4,000 m.a.s.l.
* were claustrophobic

Primary outcomes:
measure: Change of Harvey Bradshaw Activity Index (HBI)
timeFrame: 4 weeks
measure: Change of partial Mayo Score
timeFrame: 4 weeks
Secondary outcomes:
measure: change in levels of hypoxia-inducible factor (HIF)-1
timeFrame: 4 weeks
measure: Change in bladder volume
timeFrame: 4 weeks
measure: Change in levels of angiotensin and vasopressin in urine
timeFrame: 4 weeks
measure: Change in levels of catecholamines (adrenaline and noradrenaline) in blood
timeFrame: 4 weeks
measure: Change in pro- and anti-inflammatory cytokins
timeFrame: 4 weeks
measure: Inflammation in sigmoid colon
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich
name: Stephan R Vavricka, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vavricka S, Ruiz PA, Scharl S, Biedermann L, Scharl M, de Valliere C, Lundby C, Wenger RH, Held L, Merz TM, Gassmann M, Lutz T, Kunz A, Bron D, Fontana A, Strauss L, Weber A, Fried M, Rogler G, Zeitz J. 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. 2017 Jan 5;7(1):e013477. doi: 10.1136/bmjopen-2016-013477.