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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous sulfate (FeSO4) | Active Comparator | FeSO4 supplements containing 54 mg elemental iron |
|
| Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) | Experimental | Ao iron supplements containing 54 mg elemental iron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous sulfate | Dietary Supplement | 2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Individual fecal short chain fatty acid (SCFA) concentration |
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Inclusion Criteria:
Exclusion Criteria:
Self-representation of gender identity at birth
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| Name | Affiliation | Role |
|---|---|---|
| Manju B Reddy, Ph.D. | Iowa State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa State University | Ames | Iowa | 50011 | United States |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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Dietary Supplement: FeSO4 Dietary Supplement: Ao iron
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This is a double-blind study
| Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) | Dietary Supplement | 2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron) |
|
Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry. |
| Time Frame: 0-24 hours |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |