Back to resultsEngineering Gut Microbiome to Target Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breast Cancer Patients
Arm Description
All subjects will be given 2-4 weeks of probiotics prior to surgery in operable stage I-III breast adenocarcinoma tumors ≥1.0 cm. Subjects will take the probiotic three times a day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03358511
Brief Title
Engineering Gut Microbiome to Target Breast Cancer
Official Title
Engineering Gut Microbiome to Target Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
March 24, 2020 (Actual)
Study Completion Date
May 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast Cancer Patients
Arm Type
Experimental
Arm Description
All subjects will be given 2-4 weeks of probiotics prior to surgery in operable stage I-III breast adenocarcinoma tumors ≥1.0 cm. Subjects will take the probiotic three times a day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Primal Defense ULTRA Probiotic Formula
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean number of cytotoxic T lymphocytes (CD8+ cells)
Description
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.
Time Frame
Approximately 4 weeks after baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saranya Chumsri, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Engineering Gut Microbiome to Target Breast Cancer
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