RecruitingNCT05030038

Oral Aromatase Inhibitors Modify the Gut Microbiome

Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability


Sponsor

Wake Forest University Health Sciences

Enrollment

25 participants

Start Date

Mar 29, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how aromatase inhibitors — a common hormone-blocking pill used to treat breast cancer — affect the bacteria living in a patient's gut (the gut microbiome). Understanding these changes could help explain side effects and lead to better management strategies. **You may be eligible if...** - You are 18 or older - You have been diagnosed with in situ or invasive breast cancer - Your doctor is recommending you start aromatase inhibitor therapy - You are able to read, understand, and sign the consent form **You may NOT be eligible if...** - You have taken antibiotics within the past 4 weeks - You received chemotherapy within the past 4 weeks - You are currently on hormone replacement therapy or anti-estrogen therapy - You are a male with breast cancer - You have a serious unstable medical or psychiatric condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFecal swab collection

Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab

BIOLOGICALBlood samples

Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.


Locations(1)

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, United States

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NCT05030038


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