Effect of Iron Source on the Growth of Enteric Pathogens

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

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Iron Deficiency Anemia; Iron Deficiency Anemia Treatment
• Intervention / Treatment: Dietary supplement: FeSO4; Dietary supplement: Ao iron

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ferrous sulfate (FeSO4); FeSO4 supplements containing 54 mg elemental iron	Dietary supplement: FeSO4; 2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
EXPERIMENTAL: Ferrous sulfate-enriched Aspergillus oryzae (Ao iron); Ao iron supplements containing 54 mg elemental iron	Dietary supplement: Ao iron; 2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry.	0-24 hours

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2022
• Primary Completion (ACTUAL): June 20, 2022
• Study Completion (ACTUAL): June 20, 2022

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (ACTUAL): April 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases
• Other Study ID Numbers: 00002850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No