The Breast Cancer and Microbiota study is examining the impact of bacteria on the development of breast cancer.

Purpose of the study

The purpose of this study is to examine the type of bacteria that is present in your colon and determine its impact on the development of breast cancer. Normally, as human beings, we all have large amounts of bacteria that live in our large intestines (also called our colon). Medical researchers estimate that the bacteria that live in our intestines have a metabolism (ability to break things down) that is just as much as our own liver. Despite the billions of bacteria that are in our intestine, we know little about them or how they metabolize drugs and other substances such as female hormones, like estrogen.

One of the most important factors thought to play a role in breast cancer development is the female hormone called estrogen. Because the intestinal bacteria affect the circulation and absorption of female hormones such as estrogen, bacteria and the systems that metabolize female hormones in the bacteria may hold clues as to why certain people develop breast cancer and others do not.

Furthermore, some research has shown that high amounts of fat in the diet may increase the risk of breast cancer. Such higher amounts of fat can also change the types of bacteria that reside in the intestines. This is why the researchers for this study want to look at the type of bacteria and the way they metabolize female hormones and other hormones. Specifically, the researchers want to compare the bacteria in the intestines of patients who have breast cancer to those who do not have breast cancer.

Criteria for participation

The study is recruiting both patients recently diagnosed with breast cancer and healthy women. You may be eligible if you meet the following criteria:

For breast cancer patients

• Female between 50-70 years of age
• No menstrual periods for 12 months
• Recently diagnosed with breast cancer

For healthy controls

• Female between 50-70 years of age
• No menstrual periods for 12 months

Study involvement

If you choose to participate, you will have a screening visit with one of the researchers. In addition to filling out some surveys on your medical history and diet, this screening visit will include the following:

•  physical examination
•  blood work

At your follow-up visit (which may be combined with your inital visit) you will undergo a flexible sigmoidoscopy, which is one of the tools used to screen for colon cancer. This  involves having a scope inserted through your rectum into your colon.

Our research team will follow-up with you approximately 10-14 days after your flexible sigmoidoscopy and will also review your medical records for approximately one year.

Study benefits

In addition to assisting in the research to potentially find a cause for breast cancer, participants in the study will receive the following:

• study related blood work and procedure
• physician visits
• dietary assessment by the National Cancer Institute
• information regarding colon cancer
• free parking at Rush
• compensation of $100 for successful completion of the study

For more information, please call our study coordinator, Andrew Walker, at (312) 942-9203.