Engineering Gut Microbiome to Target Breast Cancer

NCT03358511 | Completed

• 1 other identifier: 17-002215
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Mean number of cytotoxic T lymphocytes (CD8+ cells)

  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

Study Arms (1)

Breast Cancer Patients

EXPERIMENTAL

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

Interventions

Probiotic DIETARY_SUPPLEMENT

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.

Also known as: Primal Defense ULTRA Probiotic Formula

Breast Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Saranya Chumsri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: November 30, 2017
• Study Start: October 11, 2017
• Primary Completion: March 24, 2020
• Study Completion: May 19, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

US (1)