The purpose of this research is to study the bacteria in participants' gut before receiving a medicine called an aromatase inhibitor for breast cancer and after participants receive medicine for breast cancer.
Primary Objective: To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment. Secondary Objective * To correlate gut microbiome populations with circulating sex hormone metabolite concentrations at baseline and 12 weeks. * To describe the correlation of change in the microbiome populations with change in circulating sex hormone metabolite concentrations from baseline to 12 weeks.
Study Type
OBSERVATIONAL
Enrollment
25
Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
RECRUITINGChange in Gut Microbial Levels - Fecal Swab
To describe the microbiome shift of gut microbiome from baseline after 4-weeks and 12-weeks of oral aromatase inhibitor treatment Investigators will calculate the change in gut microbial levels using paired t-tests.
Time frame: At baseline, 4 weeks and 12 weeks
Change in Gut Microbial Levels - Blood Samples
Investigators will calculate Pearson or Spearman correlation coefficients between diversity and gut microbial levels and circulating sex hormone metabolite concentrations at baseline and at 12 weeks. Bacterial derived bioactive compounds, bile acids, and glucuronidated sex hormones will be compared by metabolomics conducted on plasma.
Time frame: At baseline and at 12 weeks
Change in Sex Hormone Concentrations - Blood Samples
Investigators will fit a model with independent variables of the value (baseline or 12 weeks), and a second variable that represents the change from baseline (will be 0 or the change at 12 weeks). Estrone, estrone-3-glucuronide, and estrone-3-sulfate concentrations will be measured using an ELISA assay conducted on plasma.
Time frame: At baseline and at 12 weeks
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