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Probiotics and Breast Health

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: NCT03290651
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Muriel Brackstone, Lawson Health Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Dietary Supplement: Probiotic Natural Health Product - RepHresh Pro-B Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized, placebo-controlled pilot trial.
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Re-setting the Breast Microbiome to Lower Inflammation and Risk of Cancer.
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in breast microbiota [ Time Frame: 90 days post collection period ]
    The diversity of the breast microbiota analysed using next-generation sequencing.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Testing for environmental pollutants - pesticides. [ Time Frame: 90 days post collection period ]
    Urine and blood will be tested for pesticides using LC-MS.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03290651


Contacts
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Contact: Gregor Reid, Ph.D. 519-646-6100 ext 65256 gregor@uwo.ca
Contact: Shannon Seney 519-646-6100 ext 65740 shannon.seney@sjhc.london.on.ca

Locations
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Canada, Ontario
St. Joseph's Health Care Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Gregor Reid, PhD    519-646-600 ext 65120    gregor@uwo.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Gregor Reid, Ph.D. Lawson Health Research Institute
Principal Investigator: Muriel Brackstone, M.D. St. Joseph's Health Care London

Publications:

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Responsible Party: Muriel Brackstone, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03290651    
Other Study ID Numbers: 110181
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No