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Effect of Iron Supplements on the Growth of Enteric Pathogens

Primary Purpose

Iron-deficiency, Iron Deficiency Anaemia Due to Dietary Causes, Iron Deficiency Anemia Treatment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ferrous sulfate
Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)
Sponsored by
Iowa State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron-deficiency

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women 18-44 y Are able to swallow the iron pills provided for the study BMI 18.5 to 29.9 kg/m2 Willing to provide blood samples Willing to collect stool samples Exclusion Criteria: Currently taking any antibiotics Iron overload condition/hemochromatosis History of chronic gastrointestinal disorders/diseases Currently smoke cigarettes (including vaping) Have donated blood recently (in the last two weeks) Currently taking a vitamin and mineral supplement containing iron Pregnant and lactating/breastfeeding women Allergic to any of the ingredients (wheat, egg, butter, milk, and baking powder, blue dye) in the muffins

Sites / Locations

  • Iowa 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

First Posted
February 28, 2023
Last Updated
February 28, 2023
Sponsor
Iowa State University
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1. Study Identification

Unique Protocol Identification Number
NCT05762380
Brief Title
Effect of Iron Supplements on the Growth of Enteric Pathogens
Official Title
In Vitro Fecal Fermentation Following Ingestion of Iron-enriched Aspergillus Oryzae or Iron Sulfate
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
August 2, 2022 (Actual)
Study Completion Date
August 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iowa 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
Iron supplementation is a common approach to address iron deficiency with recommendations for women of childbearing age, particularly those at risk of iron deficiency. Because of its considerably higher absorption, ferrous sulphate is the common iron compound used in iron supplements. However, concerns about iron supplements arise from the knowledge that a large portion of the supplement consumed is not absorbed. This unabsorbed iron travels to the colon and, in preclinical studies, has been shown to promote the growth of 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 women of reproductive age 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 Anaemia Due to Dietary Causes, Iron Deficiency Anemia Treatment, Iron Deficiency Anemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Dietary Supplement: FeSO4 Dietary Supplement: Ao iron
Masking
ParticipantInvestigator
Masking Description
This is a double-blind study
Allocation
Randomized
Enrollment
15 (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)
Ferrous sulfate
Intervention Description
2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferrous sulfate-enriched Aspergillus oryzae (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
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
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
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
Time Frame: 0-24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-representation of gender identity at birth
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women 18-44 y Are able to swallow the iron pills provided for the study BMI 18.5 to 29.9 kg/m2 Willing to provide blood samples Willing to collect stool samples Exclusion Criteria: Currently taking any antibiotics Iron overload condition/hemochromatosis History of chronic gastrointestinal disorders/diseases Currently smoke cigarettes (including vaping) Have donated blood recently (in the last two weeks) Currently taking a vitamin and mineral supplement containing iron Pregnant and lactating/breastfeeding women Allergic to any of the ingredients (wheat, egg, butter, milk, and baking powder, blue dye) in the muffins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manju B Reddy, Ph.D.
Organizational Affiliation
Iowa State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa State University
City
Ames
State/Province
Iowa
ZIP/Postal Code
50011
Country
United States

12. IPD Sharing Statement

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Effect of Iron Supplements on the Growth of Enteric Pathogens

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