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临床试验/NCT05762380
NCT05762380已完成不适用

In Vitro Fecal Fermentation Following Ingestion of Iron-enriched Aspergillus Oryzae or Iron Sulfate

Iowa State University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年6月14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
15
试验地点
2
主要终点
Concentration of iron taken up by enteric pathogens

研究概览

简要总结

Iron supplementation is a common approach to address iron deficiency with recommendations for women of childbearing age, particularly those at risk of iron deficiency. Because of its considerably higher absorption, ferrous sulphate is the common iron compound used in iron supplements. However, concerns about iron supplements arise from the knowledge that a large portion of the supplement consumed is not absorbed. This unabsorbed iron travels to the colon and, in preclinical studies, has been shown to promote the growth of 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 women of reproductive age 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
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women 18-44 y
  • Are able to swallow the iron pills provided for the study
  • BMI 18.5 to 29.9 kg/m2
  • Willing to provide blood samples
  • Willing to collect stool samples

排除标准

  • Currently taking any antibiotics
  • Iron overload condition/hemochromatosis
  • History of chronic gastrointestinal disorders/diseases
  • Currently smoke cigarettes (including vaping)
  • Have donated blood recently (in the last two weeks)
  • Currently taking a vitamin and mineral supplement containing iron
  • Pregnant and lactating/breastfeeding women
  • Allergic to any of the ingredients (wheat, egg, butter, milk, and baking powder, blue dye) in the muffins

结局指标

主要结局

Concentration of iron taken up by enteric pathogens

时间窗: Time Frame: 0-24 hours

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

Growth of enteric pathogens measured by optical density

时间窗: Time Frame: 0-24 hours

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

次要结局

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

研究者

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

Dr. Manju B. Reddy

Professor Doris A. Adams Endowed Chair

Iowa State University

研究点 (2)

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