Probiotics and Breast Health

NCT03290651 | Completed

• 1 other identifier: 110181
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Change in breast microbiota

  The diversity of the breast microbiota analysed using next-generation sequencing.

  90 days post collection period

Secondary Outcomes (3)

• Testing of inflammatory markers and pollutants

  90 days post collection period

• Testing for environmental pollutants - heavy metals.

  90 days post collection period

• Testing for environmental pollutants - pesticides.

  90 days post collection period

Study Arms (2)

Probiotic Natural Health Product - RepHresh Pro-B

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo. It is the same composition as the active capsule, without the bacteria.

Dietary Supplement: Placebo

Interventions

Probiotic Natural Health Product - RepHresh Pro-B DIETARY_SUPPLEMENT

Participants will take the probiotic or placebo daily for 90 days.

Probiotic Natural Health Product - RepHresh Pro-B

Placebo DIETARY_SUPPLEMENT

Participants will take the probiotic or placebo daily for 90 days.

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (11)

• Arroyo R, Martin V, Maldonado A, Jimenez E, Fernandez L, Rodriguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763.

  PMID: 20455694 BACKGROUND

• Urbaniak C, Cummins J, Brackstone M, Macklaim JM, Gloor GB, Baban CK, Scott L, O'Hanlon DM, Burton JP, Francis KP, Tangney M, Reid G. Microbiota of human breast tissue. Appl Environ Microbiol. 2014 May;80(10):3007-14. doi: 10.1128/AEM.00242-14. Epub 2014 Mar 7.

  PMID: 24610844 BACKGROUND

• Urbaniak C, Gloor GB, Brackstone M, Scott L, Tangney M, Reid G. The Microbiota of Breast Tissue and Its Association with Breast Cancer. Appl Environ Microbiol. 2016 Jul 29;82(16):5039-48. doi: 10.1128/AEM.01235-16. Print 2016 Aug 15.

  PMID: 27342554 BACKGROUND

• Hieken TJ, Chen J, Hoskin TL, Walther-Antonio M, Johnson S, Ramaker S, Xiao J, Radisky DC, Knutson KL, Kalari KR, Yao JZ, Baddour LM, Chia N, Degnim AC. The Microbiome of Aseptically Collected Human Breast Tissue in Benign and Malignant Disease. Sci Rep. 2016 Aug 3;6:30751. doi: 10.1038/srep30751.

  PMID: 27485780 BACKGROUND

• Chan AA, Bashir M, Rivas MN, Duvall K, Sieling PA, Pieber TR, Vaishampayan PA, Love SM, Lee DJ. Characterization of the microbiome of nipple aspirate fluid of breast cancer survivors. Sci Rep. 2016 Jun 21;6:28061. doi: 10.1038/srep28061.

  PMID: 27324944 BACKGROUND

• Zackular JP, Baxter NT, Iverson KD, Sadler WD, Petrosino JF, Chen GY, Schloss PD. The gut microbiome modulates colon tumorigenesis. mBio. 2013 Nov 5;4(6):e00692-13. doi: 10.1128/mBio.00692-13.

  PMID: 24194538 BACKGROUND

• Mira-Pascual L, Cabrera-Rubio R, Ocon S, Costales P, Parra A, Suarez A, Moris F, Rodrigo L, Mira A, Collado MC. Microbial mucosal colonic shifts associated with the development of colorectal cancer reveal the presence of different bacterial and archaeal biomarkers. J Gastroenterol. 2015 Feb;50(2):167-79. doi: 10.1007/s00535-014-0963-x. Epub 2014 May 9.

  PMID: 24811328 BACKGROUND

• Sitas F. Twenty five years since the first prospective study by Forman et al. (1991) on Helicobacter pylori and stomach cancer risk. Cancer Epidemiol. 2016 Apr;41:159-64. doi: 10.1016/j.canep.2016.02.002. Epub 2016 Feb 26.

  PMID: 26922171 BACKGROUND

• Macklaim JM, Clemente JC, Knight R, Gloor GB, Reid G. Changes in vaginal microbiota following antimicrobial and probiotic therapy. Microb Ecol Health Dis. 2015 Aug 14;26:27799. doi: 10.3402/mehd.v26.27799. eCollection 2015.

  PMID: 26282697 BACKGROUND

• Bisanz JE, Enos MK, Mwanga JR, Changalucha J, Burton JP, Gloor GB, Reid G. Randomized open-label pilot study of the influence of probiotics and the gut microbiome on toxic metal levels in Tanzanian pregnant women and school children. mBio. 2014 Oct 7;5(5):e01580-14. doi: 10.1128/mBio.01580-14.

  PMID: 25293764 BACKGROUND

• Bisanz JE, Seney S, McMillan A, Vongsa R, Koenig D, Wong L, Dvoracek B, Gloor GB, Sumarah M, Ford B, Herman D, Burton JP, Reid G. A systems biology approach investigating the effect of probiotics on the vaginal microbiome and host responses in a double blind, placebo-controlled clinical trial of post-menopausal women. PLoS One. 2014 Aug 15;9(8):e104511. doi: 10.1371/journal.pone.0104511. eCollection 2014.

  PMID: 25127240 BACKGROUND

Study Officials

• Gregor Reid, Ph.D.

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

• Muriel Brackstone, M.D.

  St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blind randomized, placebo-controlled pilot trial.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 25, 2017
• Study Start: July 2, 2019
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)