The Altitude Inflammatory Bowel Disease Study
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
| Son Doğrulandı: | 06/30/2016 |
| İlk Gönderilen: | 07/11/2016 |
| Tahmini Kayıt Gönderildi: | 07/25/2016 |
| İlk Gönderilen: | 07/28/2016 |
| Son Güncelleme Gönderildi: | 07/25/2016 |
| Son Güncelleme Gönderildi: | 07/28/2016 |
| Fiili Çalışma Başlangıç Tarihi: | 04/30/2014 |
| Tahmini Birincil Tamamlanma Tarihi: | 08/31/2015 |
| Tahmini Çalışma Tamamlanma Tarihi: | 11/30/2016 |
Durum veya hastalık
Müdahale / tedavi
Other: hypobaric pressure chamber
Other: hypobaric pressure chamber
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| Other: 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 |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | 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 |
Sonuç
Birincil Sonuç Ölçütleri
1. Change of Harvey Bradshaw Activity Index (HBI) [4 weeks]
2. Change of partial Mayo Score [4 weeks]
İkincil Sonuç Ölçütleri
1. change in levels of hypoxia-inducible factor (HIF)-1 [4 weeks]
2. Change in bladder volume [4 weeks]
3. Change in levels of angiotensin and vasopressin in urine [4 weeks]
4. Change in levels of catecholamines (adrenaline and noradrenaline) in blood [4 weeks]
5. Change in pro- and anti-inflammatory cytokins [4 weeks]
6. Inflammation in sigmoid colon [4 weeks]
