IRB Study Number 20-239
Status Recruiting
Location Cleveland Clinic Main Campus
Institutes Digestive Disease & Surgery Institute, Taussig Cancer Institute
Description
The objectives of this study are to determine the efficacy profile of the novel probiotic; 2) To analyze bacteriome and mycobiome profiles as well as polymicrobial biofilm composition from breast tissue after consumption of the probiotic and stool before and after consumption of the probiotic; and 3) To compare quality of life (QoL) via standardized European Organization for Research and Treatment of Cancer (EORTC) instruments of those receiving novel probiotic to placebo.
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 1.5 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
BMI between 18.5 to 29.9 kg/m2
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).
Subjects with unstable medical conditions.
Clinically significant abnormal laboratory results
Any radiation/chemotherapy for current breast cancer diagnosis
Any prior breast cancer diagnosis and/or treatment
13 Any other 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.
