Breast Cancer
Conditions
Brief summary
The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.
Interventions
DIETARY_SUPPLEMENTProbiotic
Primal Defense Ultra® Probiotic Formula is an over-the-counter probiotic that provides 15 billion colony forming units of 13 species of beneficial bacteria, including Saccharomyces boulardii, Lactobacillus plantarum, Bacillus subtilis, Bifidobacterium lactis, Bifidobacterium bifidum, Lactobacillus rhamnosus, Bifidobacterium breve, lactobacillus casei, Lactobacillus salivarius, Lactobacillus acidophilus, Lactobacillus brevis, Bifidobacterium longum, and Lactobacillus paracasei.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Post-menopausal females ≥ 18 years of age * Histologically confirmed adenocarcinoma of the breast ≥1.0 cm operable stage I-III * Must have adequate organ function, * Not receive systemic neoadjuvant therapy * Be willing to provide tissue, blood, and stool samples for research study. * Must not have taken any probiotics in the past 60 days prior to enrollment.
Exclusion criteria
* Patients with autoimmune disease, immune deficiency such as HIV, irritable bowel, known diverticulosis, and other serious GI conditions at treating physician's discretion will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of cytotoxic T lymphocytes (CD8+ cells) | Approximately 4 weeks after baseline | CD8+ T cells (often called cytotoxic T lymphocytes) are very important for immune defence against intracellular pathogens, including viruses and bacteria, and for tumor surveillance. |
Countries
United States
Outcome results
None listed