Engineering Gut Microbiome to Target Breast Cancer

Mayo Clinic

Status: Completed

Conditions: Breast Cancer

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03358511

17-002215

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Breast Cancer Patients

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic