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Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens
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.
Age
5 - 12 years
Sex
ALL
Healthy Volunteers
Yes
Florida State University
Tallahassee, Florida, United States
Start Date
March 18, 2022
Primary Completion Date
June 20, 2022
Completion Date
June 20, 2022
Last Updated
June 22, 2022
10
ACTUAL participants
FeSO4
DIETARY_SUPPLEMENT
Ao iron
DIETARY_SUPPLEMENT
Lead Sponsor
Florida State University
NCT05407987
NCT06662045
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