Engineering Gut Microbiome to Target Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03358511|
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Dietary Supplement: Probiotic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Engineering Gut Microbiome to Target Breast Cancer|
|Actual Study Start Date :||October 11, 2017|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Breast Cancer Patients
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.
Dietary Supplement: Probiotic
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.
Other Name: Primal Defense ULTRA Probiotic Formula
- Mean number of cytotoxic T lymphocytes (CD8+ cells) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358511
|Contact: Dominique D Johnson||904-953-3815||Johnson.Dominique@mayo.edu|
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator: Saranya Chumsri|
|Principal Investigator:||Saranya Chumsri, MD||Mayo Clinic|