The Altitude Inflammatory Bowel Disease Study

University of Zurich (UZH)

Status: Unknown

Conditions: Inflammatory Bowel Disease

Treatments: Other: hypobaric pressure chamber; Other: Sigmoidoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02849821

VAV003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 1 patient group

hypobaric pressure chamber

Other group

Description:

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.

Treatment:

Other: Sigmoidoscopy

Other: hypobaric pressure chamber