NCT05314062

Effect of Iron Source on the Growth of Enteric Pathogens

Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Iron-deficiency
• Iron Deficiency Anemia
• Iron Deficiency Anemia Treatment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	FeSO4	2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
DIETARY_SUPPLEMENT	Ao iron	2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Timeline

• Start date: 2022-03-18
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2022-04-06
• Last updated: 2022-06-22

Locations

1 site across 1 country: United States