Engineering Gut Microbiome to Target Breast Cancer

May 19, 2020 updated by: Saranya Chumsri, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Primal Defense ULTRA Probiotic Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 4 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Saranya Chumsri, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2017

Primary Completion (Actual)

March 24, 2020

Study Completion (Actual)

May 19, 2020

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-002215

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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