The Altitude Inflammatory Bowel Disease Study

NCT02849821 | Unknown

• 1 other identifier: VAV003
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

• Change of Harvey Bradshaw Activity Index (HBI)

  Harvey Bradshaw Activity Index (HBI) in Crohn's disease (CD): To calculate the clinical activity of patients with CD the Harvey Bradshaw Activity Index (HBI) was used. This index includes general wellbeing, abdominal pain, the number of bowel movements, abdominal resistance and CD associated extraintestinal diseases. Each category has a point value assigned and from the sum of all categories a point value is calculated.

  4 weeks

• Change of partial Mayo Score

  partial Mayo Score for Ulcerative Colitis (UC): To calculate the clinical activity of patients with UC the partial Mayo Score was used. This clinical index includes the stool frequency, the amount of blood in the stool and the physician rating of disease activity. Each category has a point value assigned from 0 to 3 and from the sum of all categories a point value was calculated. Remission is defined as 0-1 points, mild disease 2-4 points, moderate disease 5-6 points and severe disease as 7-9 points.

  4 weeks

Secondary Outcomes (6)

• change in levels of hypoxia-inducible factor (HIF)-1

  4 weeks

• Change in bladder volume

  4 weeks

• Change in levels of angiotensin and vasopressin in urine

  4 weeks

• Change in levels of catecholamines (adrenaline and noradrenaline) in blood

  4 weeks

• Change in pro- and anti-inflammatory cytokins

  4 weeks

Study Arms (1)

hypobaric pressure chamber

OTHER

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.

Other: hypobaric pressure chamber; Other: Sigmoidoscopy

Interventions

hypobaric pressure chamber 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

hypobaric pressure chamber

Sigmoidoscopy 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).

hypobaric pressure chamber

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• gave written consent
• were in clinical remission (measured by Harvey Bradshaw Activity Index (HBI) in CD and the partial Mayo Score for UC)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Triemli Hospital: collaborator
• Zurich Center for Integrative Human Physiology: collaborator
• Institute of Biostatistics: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Institute of Physiology Irchel: collaborator
• Institute of Veterinary Physiology: collaborator
• Swiss Aeromedical Center Switzerland: collaborator
• Institute of Experimental Immunology: collaborator
• University Hospital, Zürich: collaborator

Related Publications (2)

• Vavricka SR, Zeitz J, Madanchi M, Ruiz PA, Biedermann L, Morsy Y, Yilmaz B, Scharl M, Scharl S, Gassmann M, Lutz TA, Kunz A, Bron D, Misselwitz B, MacPherson AJ, Rogler G, Greuter T. A Prospective Interventional Study to Evaluate the Effect of Hypoxia on Healthy Volunteers and Patients With Inflammatory Bowel Disease: The Altitude Inflammatory Bowel Disease Study. Am J Gastroenterol. 2025 Dec 16. doi: 10.14309/ajg.0000000000003888. Online ahead of print.

  PMID: 41400272 DERIVED

• 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.

  PMID: 28057654 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Sigmoidoscopy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Stephan R Vavricka, Prof. Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 29, 2016
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-07