NCT05762380

Effect of Iron Supplements on the Growth of Enteric Pathogens

In Vitro Fecal Fermentation Following Ingestion of Iron-enriched Aspergillus Oryzae or Iron Sulfate

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Iowa State University · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Iron-deficiency
• Iron Deficiency Anaemia Due to Dietary Causes
• Iron Deficiency Anemia Treatment
• Iron Deficiency Anemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ferrous sulfate	2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
DIETARY_SUPPLEMENT	Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)	2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Timeline

• Start date: 2022-06-14
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2023-03-09
• Last updated: 2023-03-09

Locations

1 site across 1 country: United States