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Inflammatory Bowel DiseaseNCT02849821

The Altitude Inflammatory Bowel Disease Study

A study testing hypobaric pressure chamber and Sigmoidoscopy in people with Inflammatory Bowel Disease, run by University of Zurich.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Inflammatory Bowel Disease
What is being tested?
hypobaric pressure chamber and Sigmoidoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
May 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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

About this study

Official title: A Study on the Influence of Hypoxia on Healthy Volunteers and Patients With Inflammatory Bowel Disease (IBD): The Altitude IBD Study

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.

Read the 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.

Being tested
hypobaric pressure chamber, Sigmoidoscopy
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hypobaric pressure chamberOther

    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

  • SigmoidoscopyOther

    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).

Study groups in NCT02849821
Study groupRoleWhat they receive
hypobaric pressure chamberOtherThe 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.
Receives: Other: hypobaric pressure chamber; Other: Sigmoidoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 weeks

  2. 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.

    Measured: 4 weeks

Secondary outcomes (6)

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

    Measured: 4 weeks

  2. Change in bladder volume

    measured by sonography (ml)

    Measured: 4 weeks

  3. Change in levels of angiotensin and vasopressin in urine

    Measured: 4 weeks

  4. Change in levels of catecholamines (adrenaline and noradrenaline) in blood

    Measured: 4 weeks

  5. Change in pro- and anti-inflammatory cytokins

    tumor necrosis factor alpha (TNF-α), tumor necrosis factor (TNF), interleukin-1β (IL-1β), interferon-gamma (IFNg), interleukin-10 (IL-10)

    Measured: 4 weeks

  6. Inflammation in sigmoid colon

    Assessed by sigmoidoscopy:

    signs of inflammation:

    • decreased vascular pattern
    • ulcers
    • bleeding

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2016 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2015
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02849821
Sponsor's protocol ID
VAV003
Status last verified
Jul 2016
First submitted
12 Jul 2016
Last updated
29 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 41400272

  • 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.

    PubMed 28057654

Questions about this trial

What is this clinical trial studying?

A study testing hypobaric pressure chamber and Sigmoidoscopy in people with Inflammatory Bowel Disease, run by University of Zurich.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Harvey Bradshaw Activity Index (HBI) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02849821, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.

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