Microbiome of Donor Iron Deficient Study (DIDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in fecal indoles
研究概览
简要总结
The goal of this pilot study is to test whether the microbiome is affected by intravenous iron repletion.
详细描述
The colonic microbiome, the community of bacteria living in our gut, is essential in human health and disease. Iron is an essential nutrient for both bacteria and humans. In the United States, of the donors who provided the ~15 million units of red blood cells that were collected for transfusion, 69% were repeat donors. Although iron deficiency is surprisingly prevalent in first-time donors, its prevalence is even higher in these particularly altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors, respectively), manifested as iron depletion or iron-deficient erythropoiesis. Iron deficiency from blood donation is associated with fatigue, restless leg syndrome, decreased physical endurance and work capacity, and impaired concentration, attention, and other neurocognitive functions; however, these conclusions are not based on definitive studies and have not yet changed blood donation policy. The goal is to conduct a prospective, double-blind, randomized controlled trial, recruiting 60 healthy regular donors who meet donation standards, while exhibiting iron-deficient erythropoiesis by laboratory test criteria. In this ancillary study, we will determine what effect donor iron deficiency and IV iron repletion have on the gut microbiome.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current participant of the associated randomized controlled trial conducted at Columbia University Medical Center (therefore invited to participate in this optional ancillary study).
排除标准
- •Not a current participant of the associated randomized controlled trial conducted at Columbia University Medical Center.
结局指标
主要结局
Change in fecal indoles
时间窗: Baseline, 5-days, 4-weeks, 5 months
Indole concentrations measured in fecal samples
Change in overall diversity of fecal flora
时间窗: Baseline, 5-days, 4-weeks, 5 months
Stool samples will be collected and processed.
Change in fecal iron
时间窗: Baseline, 5-days, 4-weeks, 5 months
Iron concentrations measured in fecal samples
次要结局
- Mean Bray-Curtis indices(Baseline, 5-days, 4-weeks, 5 months)
