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临床试验/NCT02990988
NCT02990988已完成不适用

Microbiome of Donor Iron Deficient Study (DIDS)

Columbia University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年1月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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