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The World Health Organization recommends daily iron supplementation for infants and children (6 months-12 years). Based on the low cost and high bioavailability and efficacy, ferrous sulfate is typically the first choice for supplementation and fortification. The recommended dose of iron is set high to deliver adequate absorbed iron due to low rates of dietary iron absorption, which is typically <10%. Thus, the majority of dietary iron is not absorbed and travels to the colon. Unabsorbed iron in the colon may select for 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 children 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 |
|---|---|---|---|---|
| FeSO4 | 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. | 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. | 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. | 0-24 hours |
| Individual fecal short chain fatty acid (SCFA) concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States |
IPD will not be shared with other researchers.
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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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This is a double-blind study
| 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.
| 0-24 hours |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |