A Randomized, Double-blind, Placebo-controlled Trial of Rifaximin, a Non-absorbable Antibiotic, in the Treatment of Tropical Enteropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 主要终点
- Difference in the Urinary L:M Ratio Before and After the Intervention
研究概览
简要总结
The purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of African children at high risk for this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •live in single village
排除标准
- •acutely malnourished
- •acutely ill
- •chronic disease
研究组 & 干预措施
Rifaximin
干预措施: Rifaximin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in the Urinary L:M Ratio Before and After the Intervention
时间窗: 28 days
To initiate the test, each child drank a 100 ml sugar solution containing 5 g lactulose, 1 g mannitol, 1 g sucralose, and 10 g sucrose. Children remained at the village research site for 4 h after ingestion of the sugar solution, during which time all of the child's urine was collected in a sterile cup with 10 mg merthiolate added to limit the bacterial degradation of excreted sugars. The reported values for normal L:M range from 0.03 to 0.12. A value of ≥0.10 was chosen to be indicative of tropical enteropathy. This test was performed at enrollment and then 28 days later.
次要结局
未报告次要终点