Effect of Iron Supplements on the Growth of Enteric Pathogens

Sponsor

Iowa State University (Other)

Overall Status

Completed

CT.gov ID

NCT05762380

Collaborator

(none)

Enrollment

Location

Arms

1.6

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Iron-deficiency Iron Deficiency Anaemia Due to Dietary Causes Iron Deficiency Anemia Treatment Iron Deficiency Anemia	Dietary Supplement: Ferrous sulfate Dietary Supplement: Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Dietary Supplement: FeSO4 Dietary Supplement: Ao ironDietary Supplement: FeSO4 Dietary Supplement: Ao iron

Masking:

Double (Participant, Investigator)

Masking Description:

This is a double-blind study

Primary Purpose:

Basic Science

Official Title:

In Vitro Fecal Fermentation Following Ingestion of Iron-enriched Aspergillus Oryzae or Iron Sulfate

Actual Study Start Date :

Jun 14, 2022

Actual Primary Completion Date :

Aug 2, 2022

Actual Study Completion Date :

Aug 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ferrous sulfate (FeSO4) FeSO4 supplements containing 54 mg elemental iron	Dietary Supplement: Ferrous sulfate 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: Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) 2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Arm

Intervention/Treatment

Active Comparator: Ferrous sulfate (FeSO4)

FeSO4 supplements containing 54 mg elemental iron

Dietary Supplement: Ferrous sulfate

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: Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

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

Outcome Measures

Primary Outcome Measures

Concentration of iron taken up by enteric pathogens [Time Frame: 0-24 hours]
Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.
Growth of enteric pathogens measured by optical density [Time Frame: 0-24 hours]
Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.

Secondary Outcome Measures

Gut microbiome composition and diversity [Time Frame: 0-24 hours]
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 [Time Frame: 0-24 hours]
Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iowa State University	Ames	Iowa	United States	50011

Sponsors and Collaborators

Iowa State University

Investigators

Principal Investigator: Manju B Reddy, Ph.D., Iowa State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Manju B. Reddy, Professor Doris A. Adams Endowed Chair, Iowa State University

ClinicalTrials.gov Identifier:

NCT05762380

Other Study ID Numbers:

IVFE

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 9, 2023

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anemia

Anemia, Iron-Deficiency

Deficiency Diseases

Study Results

No Results Posted as of Mar 9, 2023