The goal of this pilot study is to test whether the microbiome is affected by intravenous iron repletion.
The colonic microbiome, the community of bacteria living in our gut, is essential in human health and disease. Iron is an essential nutrient for both bacteria and humans. In the United States, of the donors who provided the \~15 million units of red blood cells that were collected for transfusion, 69% were repeat donors. Although iron deficiency is surprisingly prevalent in first-time donors, its prevalence is even higher in these particularly altruistic frequent donors, (i.e., up to 49% and 66% of male and female repeat donors, respectively), manifested as iron depletion or iron-deficient erythropoiesis. Iron deficiency from blood donation is associated with fatigue, restless leg syndrome, decreased physical endurance and work capacity, and impaired concentration, attention, and other neurocognitive functions; however, these conclusions are not based on definitive studies and have not yet changed blood donation policy. The goal is to conduct a prospective, double-blind, randomized controlled trial, recruiting 60 healthy regular donors who meet donation standards, while exhibiting iron-deficient erythropoiesis by laboratory test criteria. In this ancillary study, we will determine what effect donor iron deficiency and IV iron repletion have on the gut microbiome.
Study Type
OBSERVATIONAL
Enrollment
70
Columbia University Irving Medical Center
New York, New York, United States
Change in overall diversity of fecal flora
Stool samples will be collected and processed.
Time frame: Baseline, 5-days, 4-weeks, 5 months
Change in fecal indoles
Indole concentrations measured in fecal samples
Time frame: Baseline, 5-days, 4-weeks, 5 months
Change in fecal iron
Iron concentrations measured in fecal samples
Time frame: Baseline, 5-days, 4-weeks, 5 months
Mean Bray-Curtis indices
Calculation of Bray-Curtis index will determine the relative abundance of specific taxa (e.g., Firmicutes, Bacteroidetes, Proteobacteria) for each subject. Means (of the differences in %) and standard deviations will be calculated for all comparisons, and a multivariable generalized estimating equations (GEE) model will be used to test for significance.
Time frame: Baseline, 5-days, 4-weeks, 5 months
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