NCT03290651

Probiotics and Breast Health

Completed NA Last updated 6 April 2022

What this trial tests

NA trial testing Probiotic Natural Health Product - RepHresh Pro-B in Breast Cancer Female in 60 participants. Completed in 31 December 2021.

Timeline

2 July 2019

Primary endpoint
31 July 2021

31 December 2021

Quick facts

Lead sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	60
Start date	2 July 2019
Primary completion	31 July 2021
Estimated completion	31 December 2021
Sites	1 location across Canada

Drugs / interventions tested

• Probiotic Natural Health Product - RepHresh Pro-B
• Placebo

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →

Sponsor

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

Who can join

Eligibility, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut Microbiota and Cancer: From Pathogenesis to Therapy.
   Vivarelli S, Salemi R, Candido S, Falzone L, et al · · 2019 · cited 344× · PMID 30609850 · DOI 10.3390/cancers11010038
2. Role of the gut microbiota in anticancer therapy: from molecular mechanisms to clinical applications.
   Zhao LY, Mei JX, Yu G, Lei L, et al · · 2023 · cited 211× · PMID 37179402 · DOI 10.1038/s41392-023-01406-7
3. The gut microbiota in breast cancer development and treatment: The good, the bad, and the useful!
   Nandi D, Parida S, Sharma D. · · 2023 · cited 55× · PMID 37305949 · DOI 10.1080/19490976.2023.2221452
4. Microbial Alterations and Risk Factors of Breast Cancer: Connections and Mechanistic Insights.
   Parida S, Sharma D. · · 2020 · cited 52× · PMID 32354130 · DOI 10.3390/cells9051091
5. Gut Microbiota and Breast Cancer: The Dual Role of Microbes.
   Álvarez-Mercado AI, Del Valle Cano A, Fernández MF, Fontana L. · · 2023 · cited 50× · PMID 36672391 · DOI 10.3390/cancers15020443
6. Modulating Microbiota as a New Strategy for Breast Cancer Prevention and Treatment.
   Wu H, Ganguly S, Tollefsbol TO. · · 2022 · cited 40× · PMID 36144329 · DOI 10.3390/microorganisms10091727
7. Role of Gut Microbiota in Breast Cancer and Drug Resistance.
   Viswanathan S, Parida S, Lingipilli BT, Krishnan R, et al · · 2023 · cited 38× · PMID 36986390 · DOI 10.3390/pathogens12030468
8. Gut microbiome homeostasis and the future of probiotics in cancer immunotherapy.
   Singh A, Alexander SG, Martin S. · · 2023 · cited 35× · PMID 37261348 · DOI 10.3389/fimmu.2023.1114499