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The Altitude Inflammatory Bowel Disease Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02849821
Recruitment Status : Unknown
Verified July 2016 by University of Zurich.
Recruitment status was:  Active, not recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Collaborators:
Triemli Hospital
Zurich Center for Integrative Human Physiology
Institute of Biostatistics
University Hospital Inselspital, Berne
Institute of Physiology Irchel
Institute of Veterinary Physiology
Swiss Aeromedical Center Switzerland
Institute of Experimental Immunology
Institute of Pathology, University Hospital Zurich
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Other: hypobaric pressure chamber Other: Sigmoidoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study on the Influence of Hypoxia on Healthy Volunteers and Patients With Inflammatory Bowel Disease (IBD): The Altitude IBD Study
Study Start Date : May 2014
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
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.
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).




Primary Outcome Measures :
  1. Change of Harvey Bradshaw Activity Index (HBI) [ Time Frame: 4 weeks ]

    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.


  2. Change of partial Mayo Score [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. change in levels of hypoxia-inducible factor (HIF)-1 [ Time Frame: 4 weeks ]
  2. Change in bladder volume [ Time Frame: 4 weeks ]
    measured by sonography (ml)

  3. Change in levels of angiotensin and vasopressin in urine [ Time Frame: 4 weeks ]
  4. Change in levels of catecholamines (adrenaline and noradrenaline) in blood [ Time Frame: 4 weeks ]
  5. Change in pro- and anti-inflammatory cytokins [ Time Frame: 4 weeks ]
    tumor necrosis factor alpha (TNF-α), tumor necrosis factor (TNF), interleukin-1β (IL-1β), interferon-gamma (IFNg), interleukin-10 (IL-10)

  6. Inflammation in sigmoid colon [ Time Frame: 4 weeks ]

    Assessed by sigmoidoscopy:

    signs of inflammation:

    • decreased vascular pattern
    • ulcers
    • bleeding



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849821


Sponsors and Collaborators
University of Zurich
Triemli Hospital
Zurich Center for Integrative Human Physiology
Institute of Biostatistics
University Hospital Inselspital, Berne
Institute of Physiology Irchel
Institute of Veterinary Physiology
Swiss Aeromedical Center Switzerland
Institute of Experimental Immunology
Institute of Pathology, University Hospital Zurich
Investigators
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Principal Investigator: Stephan R Vavricka, Prof. Dr. University of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02849821    
Other Study ID Numbers: VAV003
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis