In Vitro Fecal Fermentation Following Ingestion of Iron-enriched Aspergillus Oryzae or Iron Sulfate
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
- 是
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
Dr. Manju B. Reddy
Professor Doris A. Adams Endowed Chair
Iowa State University
