Effect of Iron Supplements on the Growth of Enteric Pathogens

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia Treatment; Iron-deficiency; Iron Deficiency Anaemia Due to Dietary Causes; Iron Deficiency Anemia
• Interventions: Dietary Supplement: Ferrous sulfate; Dietary Supplement: Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

• Registration Number: NCT05762380
• Lead Sponsor: Iowa State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-14
• Primary Completion: 2022-08-02
• Study Completion: 2022-08-02
• Status Verified: 2022-09
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ferrous sulfate (FeSO4)	Ferrous sulfate	FeSO4 supplements containing 54 mg elemental iron
Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)	Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)	Ao iron supplements containing 54 mg elemental iron

Primary Outcome Measures

Name	Time	Method
Concentration of iron taken up by enteric pathogens	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	Time Frame: 0-24 hours	Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.

Secondary Outcome Measures

Name	Time	Method
Gut microbiome composition and diversity	Time Frame: 0-24 hours	Gut microbiome composition will be determined in stool following in vitro fecal fermentation using 16S rRNA gene sequencing.
Individual fecal short chain fatty acid (SCFA) concentration	Time Frame: 0-24 hours	Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry.

Trial Locations

Locations (1)

Iowa State University; 🇺🇸 Ames, Iowa, United States