NCT05030038

Oral Aromatase Inhibitors Modify the Gut Microbiome

Oral Aromatase Inhibitors Modify the Gut Microbiome Effecting Estrogen Bioavailability

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

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BIOLOGICAL	Blood samples	Participants will have approximately 1 teaspoon of blood withdrawn from a vein, for research, on 2 different occasions. The total amount of blood withdrawn during the study will be approximately 2 teaspoons.

Timeline

• Start date: 2022-03-29
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2021-09-01
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States