Effect of Iron Source on the Growth of Enteric Pathogens

NCT05314062 | Completed

• 1 other identifier: 00002850
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency; Iron Deficiency Anemia; Iron Deficiency Anemia Treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Gut microbiome composition and diversity

  0-24 hours

• Individual fecal short chain fatty acid (SCFA) concentration

  0-24 hours

Study Arms (2)

Ferrous sulfate (FeSO4)

ACTIVE COMPARATOR

FeSO4 supplements containing 54 mg elemental iron

Dietary Supplement: FeSO4

Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

EXPERIMENTAL

Ao iron supplements containing 54 mg elemental iron

Dietary Supplement: Ao iron

Interventions

FeSO4 DIETARY_SUPPLEMENT

2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Ferrous sulfate (FeSO4)

Ao iron DIETARY_SUPPLEMENT

2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: April 6, 2022
• Study Start: March 18, 2022
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)