Use of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers Taking Non-steroidal Anti-inflammatory Drugs (NSAIDs)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Lactulose:rhamnose ratio - Arm1 (Urine)
研究概览
简要总结
Zinc carnosine is a food supplement which is available in the health food shops. The investigators wish to see if it can reduce intestinal swelling in people who take non-steroidal anti-inflammatory (anti-swelling) drugs (NSAIDs: non-steroidal antiinflammatory drug.).
详细描述
The study was about exploring the influence of zinc carnosine (ZnC) on changes in small bowel permeability caused by indomethacin.
Healthy volunteers (n = 10) participated in this double-blind randomised controlled crossover protocol. Each arm comprised two baseline urine collections, followed by a third at the end of that study period. In each arm, volunteers took ZnC (37.5 mg twice daily, orally) or placebo for 7 days, with indomethacin for the final 5 days.
Results were expressed as lactulose:rhamnose (L:R) ratios and mean values for each stage were therefore estimated: when taking placebo, volunteers had a threefold increase in L:R ratios in response to indomethacin administration (p,0.01), whereas no increase was seen if ZnC was also being taken.
All 10 participants completed the study without protocol violations. Two of ten participants developed mild nondescript upper abdominal discomfort while taking the indomethacin (control) arm, but completed the course. None reported symptoms during the ZnC (plus indomethacin) arm, and no side effects due to ingestion of ZnC were reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-35 years
排除标准
- •Conditions known to alter intestinal permeability, eg previous bowel surgery, celiac disease
- •Conditions where NSAIDs are contraindicated, eg asthma, renal failure, heart failure
- •Any other serious illness
结局指标
主要结局
Lactulose:rhamnose ratio - Arm1 (Urine)
时间窗: day 5
Lactulose:rhamnose urine ratio in zinc carnosine/indomethacin coadministered patients
Lactulose:rhamnose ratio - Arm2 (Urine)
时间窗: day 5
Lactulose:rhamnose urine ratio in placebo/indomethacin coadministered patients
次要结局
未报告次要终点
