Back to resultsEffect of Iron Source on the Growth of Enteric Pathogens
Primary Purpose
Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FeSO4
Ao iron
Sponsored by
About this trial
This is an interventional basic science trial for Iron-deficiency
Eligibility Criteria
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
Sites / Locations
- Florida State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ferrous sulfate (FeSO4)
Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)
Arm Description
FeSO4 supplements containing 54 mg elemental iron
Ao iron supplements containing 54 mg elemental iron
Outcomes
Primary Outcome Measures
Concentration of iron taken up by enteric pathogens
Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.
Growth of enteric pathogens measured by optical density
Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.
Secondary Outcome Measures
Gut microbiome composition and diversity
Gut microbiome composition will be determined in stool following in vitro fecal fermentation using 16S rRNA gene sequencing.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05314062
Brief Title
Effect of Iron Source on the Growth of Enteric Pathogens
Official Title
Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
This is a double-blind study
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferrous sulfate (FeSO4)
Arm Type
Active Comparator
Arm Description
FeSO4 supplements containing 54 mg elemental iron
Arm Title
Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)
Arm Type
Experimental
Arm Description
Ao iron supplements containing 54 mg elemental iron
Intervention Type
Dietary Supplement
Intervention Name(s)
FeSO4
Intervention Description
2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ao iron
Intervention Description
2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Primary Outcome Measure Information:
Title
Concentration of iron taken up by enteric pathogens
Description
Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.
Time Frame
0-24 hours
Title
Growth of enteric pathogens measured by optical density
Description
Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.
Time Frame
0-24 hours
Secondary Outcome Measure Information:
Title
Gut microbiome composition and diversity
Description
Gut microbiome composition will be determined in stool following in vitro fecal fermentation using 16S rRNA gene sequencing.
Time Frame
0-24 hours
Title
Individual fecal short chain fatty acid (SCFA) concentration
Description
Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry.
Time Frame
0-24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers.
Learn more about this trial
Effect of Iron Source on the Growth of Enteric Pathogens
We'll reach out to this number within 24 hrs