Effect of Iron Source on the Growth of Enteric Pathogens

Iron Deficiency Anemia Clinical Trial

Official title:

Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314062
• Other study ID #: 00002850
• Status: Completed
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: June 20, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• FeSO4
2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
• Ao iron
2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida 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.	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.	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.	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.	0-24 hours