Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Saranya Chumsri, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: Probiotic Not Applicable

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Dominique D Johnson 904-953-3815 Johnson.Dominique@mayo.edu

Locations
Layout table for location information
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Saranya Chumsri         
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Saranya Chumsri, MD Mayo Clinic

Additional Information:
Layout table for additonal information
Responsible Party: Saranya Chumsri, Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03358511     History of Changes
Other Study ID Numbers: 17-002215
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases