Breast Cancer Clinical Trial
Official title:
Engineering Gut Microbiome to Target Breast Cancer
NCT number | NCT03358511 |
Other study ID # | 17-002215 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 11, 2017 |
Est. completion date | May 19, 2020 |
Verified date | May 2020 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | May 19, 2020 |
Est. primary completion date | March 24, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean number of cytotoxic T lymphocytes (CD8+ cells) | 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. | Approximately 4 weeks after baseline |
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