Comparison of Gut Microbiota Composition and Systemic Inflammatory Markers Prior to and Post-Proton Pump Inhibitor Use in Older Adults
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in fecal microbiota diversity following omeprazole use
研究概览
简要总结
The purpose of this study is to evaluate the effects of a common over-the-counter medication, omeprazole, on the normal gut bacteria and inflammation in the body in healthy older adults.
详细描述
This study aims to enroll 25 healthy subjects from San Antonio, Texas and the surrounding area. Study participants will be asked to provide a blood and stool sample at baseline, complete a 14-day course of omeprazole (Prilosec®), and then complete a follow-up blood and stool sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 60 years or older
排除标准
- •No prior major gastrointestinal surgery
- •No chronic daily use or any use within the past two months of the following medications: antibiotics, proton pump inhibitors, other acid reflux medications, probiotics, anti-inflammatory medications, anti-diarrhea medications, laxatives, anti-depressants, anti-anxiety medications, steroids, metformin, or biologic/immune modulating drugs
研究组 & 干预措施
Healthy subjects
干预措施: Omeprazole (Drug)
结局指标
主要结局
Change in fecal microbiota diversity following omeprazole use
时间窗: 14 days
Bacterial taxa will be classified according to operational taxonomic units (OTUs). The change in the diversity of bacteria taxa will be compared between pre- and post-samples using the Bray-Curtis dissimilarity measure.
次要结局
- Change in interleukin inflammatory markers following omeprazole use(14 days)
- Change in tumor necrosis factor-alpha following omeprazole use(14 days)
- Change in insulin-like growth factor-1 due following omeprazole use(14 days)