Probiotics and Breast Health

April 4, 2022 updated by: Muriel Brackstone, Lawson Health Research Institute

Re-setting the Breast Microbiome to Lower Inflammation and Risk of Cancer.

Breast cancer remains a major killer of women and despite major advances in care, the role of 'environmental factors' in the disease remain to be well understood. The investigators have shown that one such factor is the bacteria that inhabit the breast tissue. These bacteria do not cause infections per se, but can produce low amounts of substances known to be able to induce cancer. The investigators have found that the bacteria in the breasts of women with cancer are very different from those found in the breast tissue of healthy women. The investigators would like to test their theory that taking probiotic lactobacilli by mouth can lead to these organisms reaching the breast tissue and help to displace the harmful bacteria and reduce inflammation which has close links to cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Certain bacteria, particularly Gram negatives, are major causes of inflammation. In fact, the lipopolysaccharides from these bacteria are used in vast numbers of studies to induce inflammation and study disease. Many cancers are the result of inflammatory processes. Breast cancer is a major cause of illness and death in women and inflammatory processes are one of the foci of investigation; however, not yet from the stand point that bacteria in the breast may be the instigators of cancer development. The investigators were the first in the world to describe the breast microbiota and show that the bacterial profiles are more pathogenic in women with cancer than in tissues of healthy controls. This work has been validated by others. Although this does not prove a cause-and-effect link with breast cancer, such linkages have been shown in stomach and colon cancers. If researchers assume there is a link, then how can the inflammatory microbiota be re-set to one that is somehow beneficial and able to reduce inflammation and potential cancer induction?

The concept of probiotics emerged from the quest to reset the disrupted microbiota of the gut and upper respiratory tract. This investigational group has led the world in doing the same in the urogenital tract of women.

The researchers would like to test their theory that taking probiotic lactobacilli by mouth can lead to these organisms reaching the breast tissue and helping displace the harmful bacteria and reducing inflammation. A study in Spain has shown that oral intake of probiotic lactobacilli can not only cure mastitis, but lead to the lactobacilli reaching the milk glands. Women who breast feed for more than six months (and thereby pass along lactic acid bacteria to the infant from the breast milk) have a reduced risk of breast cancer.

The investigators hypothesize that the breast microbiome of women at risk of cancer has the same profile as women with cancer and that oral administration of probiotic lactobacilli can reset this to one found in healthy women. They also hypothesize the breast tissue of these at-risk patients is contaminated by environmental toxins.

The project plan is to test the concept of re-setting the breast tissue microbiota in women at risk of cancer, to one more aligned with health.

Samples will be tested for relative bacterial abundance to determine any shift in bacterial breast tissue composition by next-generation sequencing and bioinformatics. Samples will also be tested for inflammatory markers using Luminex technology, and for mercury, arsenic and pesticides using LC-MS as described in previous studies.

Twenty women at high-risk for breast cancer (See Inclusion Criteria) will be randomized (10 each) to receive either probiotic or placebo, once a day for 90 days. This capsule is approved in Canada and widely available and contains 2.5 billion CFU viable bacterial cells of each of the following strains: Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14. Both active capsules and placebo will be provided by the manufacturer Chr Hansen (Denmark). Samples will be collected at t=0 (enrollment), t=1 (end of 90 days) and t=2(30 days post-treatment).

Twenty women will act as healthy controls (See Inclusion Criteria) and will be randomized (10 each) as described above for the high-risk group.

At each time point, samples collected will include:

  • Breast skin swab - a cotton tipped swab with be moistened with sterile water and the passed over the skin on the breast 10 times.
  • Needle aspirate - a 22-gauge needle into the breast tissue with repeated passage under suction until aspirate material is identified in the needle hub. This material would then be placed in normal saline.
  • Nipple aspirate - the participant will be asked to massage their breast from chest wall to nipple for several minutes as needed. Using a hand-held modified breast pump placed over the nipple, nipple aspirate fluid will be drawn out and into a capillary tube.
  • Blood draw - one 6mL EDTA plasma tube using standard phlebotomy procedures. Samples will be analyzed for relative bacterial abundance (next-generation sequencing), inflammatory markers (Luminex technology).
  • Urine - 100mL sample that will be tested for heavy metals and pesticides using LC-MS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women at high risk of developing breast cancer who have never had breast cancer (≥ 25% lifetime risk and/or BRCA1 or BRCA2 positive) will be included in the high risk group, while female family members of cancer patients or friends of patients, as well as patients to the breast clinic who are seen for other reasons not related to cancer will be offered participation in the control group.

Exclusion Criteria:

  • Exclusion criteria include: immunosuppression (ongoing high dose steroids, immunosuppressive condition such as HIV), personal history of breast cancer, patients declining needle aspiration biopsy or probiotic/placebo treatment, ongoing daily oral probiotic treatment at time of diagnosis. Patients on chronic or recent (within 2 weeks) antibiotic therapy will also 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotic Natural Health Product - RepHresh Pro-B
One capsule contains 2.5 billion CFU of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14.
Dietary supplement: Probiotic Natural Health Product - RepHresh Pro-B
Participants will take the probiotic or placebo daily for 90 days.
Placebo Comparator: Placebo
Placebo. It is the same composition as the active capsule, without the bacteria.
Dietary supplement: Placebo
Participants will take the probiotic or placebo daily for 90 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in breast microbiota
Time Frame: 90 days post collection period
The diversity of the breast microbiota analysed using next-generation sequencing.
90 days post collection period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Testing of inflammatory markers and pollutants
Time Frame: 90 days post collection period
Blood samples will be testing by luminex for inflammatory cytokine/chemokine markers.
90 days post collection period
Testing for environmental pollutants - heavy metals.
Time Frame: 90 days post collection period
Urine and blood will be tested for heavy metals using LC-MS.
90 days post collection period
Testing for environmental pollutants - pesticides.
Time Frame: 90 days post collection period
Urine and blood will be tested for pesticides using LC-MS.
90 days post collection period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregor Reid, Ph.D., Lawson Health Research Institute
  • Principal Investigator: Muriel Brackstone, M.D., St. Joseph's Health Care London

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 110181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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