Probiotic for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use antibiotics within 5 weeks of starting the trial or change anti-psychotic medications within 3 months before starting. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Novel probiotic for breast cancer?
Research suggests that probiotics might help in breast cancer treatment by improving gut health and boosting the immune system. Some studies show that certain probiotics can reduce inflammation and improve quality of life in breast cancer patients, although more research is needed to confirm these effects.12345
Is the probiotic treatment generally safe for humans?
How does the probiotic treatment for breast cancer differ from other treatments?
This probiotic treatment is unique because it uses beneficial bacteria to potentially fight breast cancer by improving gut health and boosting the immune system, unlike traditional treatments that directly target cancer cells. It involves using specific strains like Lactobacillus and Bifidobacterium, sometimes combined with prebiotics, to enhance its effects.13489
What is the purpose of this trial?
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.
Research Team
Zahraa Al-Hilli, MD
Principal Investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with a breast tumor size of at least 1.0 cm and diagnosed with invasive ductal or lobular carcinoma, who are not pregnant, breastfeeding, or planning pregnancy during the study. Participants must have a BMI between 18.5 to 29.9 kg/m2, avoid unpasteurized fermented foods and probiotics before and during the trial, maintain current diet/exercise levels, agree to use birth control if applicable, and sign informed consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the novel probiotic or placebo for 6 weeks to assess changes in microbiome and quality of life
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Novel probiotic
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor