Effect of Iron Source on the Growth of Enteric Pathogens

Not Applicable

Completed

• Conditions: Iron-deficiency; Iron Deficiency Anemia Treatment; Iron Deficiency Anemia
• Interventions: Dietary Supplement: Ao iron; Dietary Supplement: FeSO4

• Registration Number: NCT05314062
• Lead Sponsor: Florida State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-18
• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Status Verified: 2022-06
• Primary Completion: 2022-06-20
• Study Completion: 2022-06-20
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Healthy children 5-12 y
• Willing to donate stool sample

Exclusion Criteria

• Currently taking antibiotics
• Currently taking a vitamin and mineral supplement containing iron
• Wards of the state, including children in foster care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Growth of enteric pathogens measured by optical density	0-24 hours	Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.
Concentration of iron taken up by enteric pathogens	0-24 hours	Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States