The Altitude Inflammatory Bowel Disease Study

NCT ID: NCT02849821

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Inflammatory Bowel Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

hypobaric pressure chamber

The healthy volunteers and IBD patients will have 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. Before and after the pressure chamber sigmoidoscopy will be performed. During stay in the pressure chamber repetitive measurements of bladder volume will be performed by sonography.

Group Type: OTHER

hypobaric pressure chamber

Intervention Type: OTHER

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

Sigmoidoscopy

Intervention Type: OTHER

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).

Interventions

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

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Triemli Hospital

OTHER

Sponsor Role: collaborator

Zurich Center for Integrative Human Physiology

OTHER

Sponsor Role: collaborator

Institute of Biostatistics

UNKNOWN

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

Institute of Physiology Irchel

UNKNOWN

Sponsor Role: collaborator

Institute of Veterinary Physiology

UNKNOWN

Sponsor Role: collaborator

Swiss Aeromedical Center Switzerland

UNKNOWN

Sponsor Role: collaborator

Institute of Experimental Immunology

UNKNOWN

Sponsor Role: collaborator

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan R Vavricka, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

References

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.

Reference Type: DERIVED

PMID: 28057654 (View on PubMed)

Other Identifiers

VAV003

Identifier Type: -

Identifier Source: org_study_id