A Study on the Influence of Hypoxia on Healthy Volunteers and Patients With Inflammatory Bowel Disease (IBD): The Altitude IBD Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Change of partial Mayo Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change of partial Mayo Score
时间窗: 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 of Harvey Bradshaw Activity Index (HBI)
时间窗: 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.
次要结局
- change in levels of hypoxia-inducible factor (HIF)-1(4 weeks)
- Change in levels of angiotensin and vasopressin in urine(4 weeks)
- Change in levels of catecholamines (adrenaline and noradrenaline) in blood(4 weeks)
- Inflammation in sigmoid colon(4 weeks)
- Change in bladder volume(4 weeks)
- Change in pro- and anti-inflammatory cytokins(4 weeks)