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OpenTrials
Completed

NCT Number: NCT05762380

Effect of Iron Supplements on the Growth of Enteric Pathogens

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous Sulfate

Dietary Supplement

2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

Dietary Supplement

2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Primary outcomes

  1. Concentration of iron taken up by enteric pathogens

    Time frame: Time Frame: 0-24 hours

    Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.

  2. Growth of enteric pathogens measured by optical density

    Time frame: Time Frame: 0-24 hours

    Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.

Secondary outcomes

  1. Gut microbiome composition and diversity

    Time frame: Time Frame: 0-24 hours

    Gut microbiome composition will be determined in stool following in vitro fecal fermentation using 16S rRNA gene sequencing.

  2. Individual fecal short chain fatty acid (SCFA) concentration

    Time frame: Time Frame: 0-24 hours

    Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry.

Sponsors and collaborators

Lead sponsor

Iowa State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2023
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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