Probiotic Effect on Microbiome in Invasive Breast Cancer Patients

Inclusion Criteria

• Female between >= 18 and 65 years of age
• Diagnosis of breast cancer (invasive ductal carcinoma [IDC] or invasive lobular carcinoma [ILC])
• Minimum breast tumor size of 1.0 cm
• Subjects who are of childbearing potential must agree to use a medically approved method of birth control and have a negative pregnancy test result
• Body mass index (BMI) between 18.5 to 29.9 kg/m^2
• Agree to abstain from consuming unpasteurized bacteria-fermented foods one week prior to baseline visit and throughout the study (example list provided and reviewed during informed consent process)
• Agree to not change current dietary habits (apart from avoiding probiotics) and activity/training levels one week prior to screening and during the study
• Agree to complete all research activities defined in the study
• Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Women who are pregnant, breast feeding, or planning to become pregnant during the trial
• Use of antibiotics within 5 weeks of randomization
• History of chronic inflammation or structural abnormality of the digestive tract (e.g., inflammatory bowel disease, duodenal or gastric ulcer intestinal obstruction, or symptomatic cholelithiasis)
• Use of probiotic and/or prebiotic supplements and/or supplemented foods prior to screening and throughout the study
• Individuals receiving any other investigational agents within 30 days prior to randomization
• Change in anti-psychotic medication within 3 months prior to randomization
• Alcohol or drug abuse in the past year
• Subjects with a known allergy to the test material’s active or inactive ingredients (list provided and reviewed during informed consent process)
• Clinically significant abnormal laboratory results that may negatively impact the patient being involved on the study, at the discretion of the physician
• Any radiation/chemotherapy for current breast cancer diagnosis
• Any prior breast cancer diagnosis and/or treatment
• Any condition which in the investigators’ opinions may adversely affect the subject’s ability to complete the study or its measures or which may pose significant risk to the subject
• Physician feels participation in this trial is not in the subject’s best interest