Florida State University
Tallahassee, Florida, 32306, United States
NCT Number: NCT05314062
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.
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Notify Me5 year–12 year
All sexes
Interventional
Not applicable
Tallahassee, Florida, 32306, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Time frame: 0-24 hours
Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.
Time frame: 0-24 hours
Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.
Time frame: 0-24 hours
Gut microbiome composition will be determined in stool following in vitro fecal fermentation using 16S rRNA gene sequencing.
Time frame: 0-24 hours
Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry.
Florida State University
Other
Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens
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