100 Participants Needed

Probiotic for Breast Cancer

CE
ZA
Overseen ByZahraa Al-Hilli, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Case Comprehensive Cancer Center

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?

Probiotics have been studied for safety in various conditions, including cancer-related treatments, and are generally considered safe for human use. However, more large-scale clinical trials are needed to confirm their safety specifically for breast cancer treatment.13467

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

ZA

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

Participants must have the ability to understand and the willingness to sign a written informed consent document
My breast tumor is at least 1.0 cm in size.
Your body mass index (BMI) is between 18.5 and 29.9.
See 5 more

Exclusion Criteria

You have abnormal lab results that could affect your participation in the study, as decided by the doctor.
Any condition which in the investigators' opinions may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant
I have a history of chronic digestive issues like IBD or ulcers.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the novel probiotic or placebo for 6 weeks to assess changes in microbiome and quality of life

6 weeks
Baseline and 6-week visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Novel probiotic
Trial Overview The study tests BIOHM probiotic's effect on the microbiome in breast cancer patients compared to a placebo. BIOHM aims to balance gut bacteria/fungi and is FDA-recognized as safe (GRAS). The goal is to see if it can influence microorganisms associated with breast cancer development.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Novel probioticExperimental Treatment1 Intervention
Investigational novel probiotic plus normal standard of care for breast cancer.
Group II: PlaceboPlacebo Group1 Intervention
Placebo plus normal standard of care for breast cancer.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Findings from Research

Probiotics can help maintain a balanced gut microbiome, which is crucial for preventing pro-inflammatory responses that may lead to diseases like cancer.
Research indicates that certain probiotic strains can not only prevent cancer but also support treatment during chemotherapy by modulating the immune response and intestinal microbiota.
The Role of Probiotics in Cancer Prevention.Śliżewska, K., Markowiak-Kopeć, P., Śliżewska, W.[2021]

References

Potential effect of probiotics in the treatment of breast cancer. [2020]
The Role of Probiotics in Cancer Prevention. [2021]
Preventive effects of probiotic bacteria Lactobacillus plantarum and dietary fiber in chemically-induced mammary carcinogenesis. [2017]
Effect of Probiotics in Breast Cancer: A Systematic Review and Meta-Analysis. [2023]
Adjunctive Probiotic Lactobacillus rhamnosus Probio-M9 Administration Enhances the Effect of Anti-PD-1 Antitumor Therapy via Restoring Antibiotic-Disrupted Gut Microbiota. [2022]
The efficacy and safety of probiotics for prevention of chemoradiotherapy-induced diarrhea in people with abdominal and pelvic cancer: A systematic review and meta-analysis based on 23 randomized studies. [2021]
Beneficial bacteria stimulate host immune cells to counteract dietary and genetic predisposition to mammary cancer in mice. [2022]
Molecular identification of lactic acid bacteria SR6 strain and evaluation of its activity as an anticancer in T47D cell line. [2022]
Anticancer and Immunomodulatory Effects of Lactobacillus plantarum LS/07, Inulin and Melatonin in NMU-induced Rat Model of Breast Cancer. [2017]
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