Clinical trial NCT05762380: 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
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Iron Deficiency Anaemia Due to Dietary Causes
Iron Deficiency Anemia Treatment
Iron Deficiency Anemia
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Dietary Supplement: FeSO4 Dietary Supplement: Ao iron
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Concentration of iron taken up by enteric pathogens
timeFrame: Time Frame: 0-24 hours
measure: Growth of enteric pathogens measured by optical density
timeFrame: Time Frame: 0-24 hours
Secondary outcomes:
measure: Gut microbiome composition and diversity
timeFrame: Time Frame: 0-24 hours
measure: Individual fecal short chain fatty acid (SCFA) concentration
timeFrame: Time Frame: 0-24 hours
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
affiliation: Iowa State University
name: Manju B Reddy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: