Case Comprehensive Cancer Center
The purpose of this study is to examine the effect of probiotics on the breast tumor microbiome and gut microbiome in breast cancer. Microorganisms that make up the microbiome (such as viruses, bacteria, and fungi) may have an important role in breast cancer development. Understanding the association of microorganisms with breast cancer may enable new ways to prevent, diagnose, and treat breast cancer. The probiotic, BIOHM, which is owned and distributed by BIOHM Health LLC, will be used in this study. BIOHM is a food supplement that is believed to balance bacteria and fungi in the body and has received the designation as Generally Recognized as Safe (GRAS) by the Food and Drug Administration (FDA). This study is being done to determine the effectiveness of BIOHM in breast cancer.
This study will investigate the efficacy of the investigational product (a novel probiotic) on altering the microbiome (bacteriomeand mycobiome) and polymicrobial biofilms in the gut of 50 women with breast cancer given the novel probiotic, compared to 50 women with breast cancer given a placebo. The objectives of this study are to: 1. Determine the efficacy profile of the novel probiotic 2. Analyze bacteriome and mycobiome profiles as well as polymicrobial biofilm composition from breast tissue and stool before and after consumption of the probiotic. 3. Compare quality of life (QoL) of thos…
Inclusion Criteria: * Female \> 18 years of age * Diagnosis of breast cancer (invasive ductal carcinoma \[IDC\] or Invasive Lobular Carcinoma \[ILC\]) * Minimum breast tumor size of 1.0 cm * Participants who are of childbearing potential must agree to use a medically approved method of birth control and have a negative pregnancy test result * 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 fro…
Investigational novel probiotic
Placebo for probiotic
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.