This trial is examining the effectiveness of a probiotic (Primal Defense Ultra (R) Probiotic Formula) for the immune systems of patients with breast cancer. The main outcome to be measured is the number of cytotoxic T lymphocytes (CD8+), a type of white blood cell. This study is being conducted in the Mayo Clinic in Florida.
The details
This study is examining the use of probiotics during breast cancer treatment. Probiotics are used to help the body's immune system react to breast cancer. The bacteria commonly found in the bowel could improve the immune system, specifically the ability of the immune system to recognize cancer.
The main outcome will be measured as the change in cytotoxic T lymphocytes (CD8+), a type of white blood cell.
Who are they looking for?
This study is looking for 20 patients with an adenocarcinoma of the breast greater than or equal to 1.0 cm. The cancer must be between Stage I and III. Patients must be willing to provide tissue, blood and stool samples for research study.
Patients should not have autoimmune diseases, brain metastases, gastrointestinal disorders, or cardiovascular disease. Patients should not be starting chemotherapy, hormone therapy or targeted therapy prior to surgery. Probiotics should not be taken for 60 days before the trial starts.
How will it work
All patients will be given 2-4 weeks of probiotics before surgery. The probiotics will be taken three times a day.
T-cell levels will be measured 4 weeks after treatment.
