Engineering Gut Microbiome to Target Breast Cancer
Not Applicable
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT03358511
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 7
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic in Florida🇺🇸Jacksonville, Florida, United States