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临床试验/NCT05314062
NCT05314062已完成不适用

Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens

Florida State University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Growth of enteric pathogens measured by optical density

研究概览

简要总结

The World Health Organization recommends daily iron supplementation for infants and children (6 months-12 years). Based on the low cost and high bioavailability and efficacy, ferrous sulfate is typically the first choice for supplementation and fortification. The recommended dose of iron is set high to deliver adequate absorbed iron due to low rates of dietary iron absorption, which is typically <10%. Thus, the majority of dietary iron is not absorbed and travels to the colon. Unabsorbed iron in the colon may select for enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from children following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens and outcome measures will be determined following in vitro fecal fermentation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

This is a double-blind study

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children 5-12 y
  • Willing to donate stool sample

排除标准

  • Currently taking antibiotics
  • Currently taking a vitamin and mineral supplement containing iron
  • Wards of the state, including children in foster care

结局指标

主要结局

Growth of enteric pathogens measured by optical density

时间窗: 0-24 hours

Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.

Concentration of iron taken up by enteric pathogens

时间窗: 0-24 hours

Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.

次要结局

  • Individual fecal short chain fatty acid (SCFA) concentration(0-24 hours)
  • Gut microbiome composition and diversity(0-24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen R. Hennigar, Ph.D.

Assistant Professor

Florida State University

研究点 (2)

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