Engineering Gut Microbiome to Target Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT03358511
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-11
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-11-30
• Primary Completion: 2020-03-24
• Status Verified: 2020-05
• Study Completion: 2020-05-19
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast Cancer Patients	Probiotic	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.

Primary Outcome Measures

Name	Time	Method
Mean number of cytotoxic T lymphocytes (CD8+ cells)	Approximately 4 weeks after baseline	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States