Oral Aromatase Inhibitors Modify the Gut Microbiome

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05030038
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fecal swab collection — BIOLOGICAL
    Participants will collect fecal sample at home and either mail in the sample, or drop it off at the lab
  • Blood samples — BIOLOGICAL
    Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.

Study Details

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.

Key Dates

Start date
Mar 29, 2022
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: Aromatase inhibitor for breast cancer treatment
    Participants will receive their standard of care for breast cancer treatment which includes an aromatase inhibitor. Pre-study assessments will be done at baseline as well as stool and blood samples at baseline, then again at 4 weeks and at 12 weeks during the course of the trial.

Primary Outcome Measure

Change in Gut Microbial Levels - Fecal Swab [ Time Frame: At baseline, 4 weeks and 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Health SciencesWinston-SalemNorth Carolina27157
Study Coordinator
[email protected]
336-713-5435
Katherine Ansley, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Wake Forest Baptist Health Sciences· Winston-Salem, NC

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