Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens
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
- 是
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
Stephen R. Hennigar, Ph.D.
Assistant Professor
Florida State University
