Effect of Iron Supplements on the Growth of Enteric Pathogens

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05762380
• Other study ID #: IVFE
• Status: Completed
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: August 2, 2022

Study information

• Verified date: September 2022
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia
• Iron Deficiency Anemia Treatment
• Iron-deficiency

Intervention

Dietary Supplement:
• Ferrous sulfate
2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
• Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)
2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Locations

Country	Name	City	State
United States	Iowa State University	Ames	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Iowa State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of iron taken up by enteric pathogens	Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.	Time Frame: 0-24 hours
Primary	Growth of enteric pathogens measured by optical density	Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.	Time Frame: 0-24 hours
Secondary	Gut microbiome composition and diversity	Gut microbiome composition will be determined in stool following in vitro fecal fermentation using 16S rRNA gene sequencing.	Time Frame: 0-24 hours
Secondary	Individual fecal short chain fatty acid (SCFA) concentration	Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry.	Time Frame: 0-24 hours