The Altitude Inflammatory Bowel Disease Study
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|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
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease||Other: hypobaric pressure chamber Other: Sigmoidoscopy||Not Applicable|
|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|
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
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).
- 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.
- 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.
- change in levels of hypoxia-inducible factor (HIF)-1 [ Time Frame: 4 weeks ]
- Change in bladder volume [ Time Frame: 4 weeks ]measured by sonography (ml)
- Change in levels of angiotensin and vasopressin in urine [ Time Frame: 4 weeks ]
- Change in levels of catecholamines (adrenaline and noradrenaline) in blood [ Time Frame: 4 weeks ]
- 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)
- Inflammation in sigmoid colon [ Time Frame: 4 weeks ]
Assessed by sigmoidoscopy:
signs of inflammation:
- decreased vascular pattern
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
|Principal Investigator:||Stephan R Vavricka, Prof. Dr.||University of Zurich|