Probiotic for Breast Cancer

Overseen By Zahraa Al-Hilli, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Pregnancy, Digestive disorders, Alcohol abuse, others

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a probiotic supplement called BIOHM affects microorganisms in the breast and gut of people with breast cancer. Researchers aim to determine if balancing bacteria and fungi in the body can aid in preventing, diagnosing, or treating breast cancer. Participants will receive either BIOHM alongside their usual breast cancer treatment or a placebo. Individuals with a breast cancer diagnosis and a tumor size of at least 1.0 cm may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new insights in breast cancer treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that probiotics, like the one under study, might help protect against breast cancer by influencing the body's microbiome, which consists of beneficial bacteria and fungi. The probiotic used in this study, called BIOHM, is considered safe by the FDA due to its previous use in food or proven safety through research.

Some studies have found that certain probiotics can inhibit cancer cell growth by boosting the body's immune system. Although using this specific probiotic for breast cancer is new, its safety is supported by its FDA status, indicating it is generally well-tolerated as a supplement. However, like any treatment, side effects may occur, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for breast cancer, which often include surgery, chemotherapy, radiation, and hormone therapy, this novel probiotic offers a unique approach by potentially enhancing the body's natural defenses. Researchers are excited about this probiotic because it introduces beneficial bacteria that might improve gut health, potentially impacting the immune system's ability to fight cancer. This represents a new mechanism of action, as it aims to support the body’s natural processes rather than directly targeting cancer cells with chemicals or radiation. By incorporating this probiotic alongside standard care, there is hope for improved patient outcomes with fewer side effects.

What evidence suggests that this probiotic might be an effective treatment for breast cancer?

Research suggests that probiotics might aid in the fight against cancer. Many studies have shown that probiotics can help control cancer by promoting cancer cell death and slowing their growth. Certain probiotics have been found to affect the gut and areas around tumors in ways that might assist in treating breast cancer. In this trial, participants will receive either a novel probiotic or a placebo, both alongside the standard care for breast cancer. However, more research is needed to confirm the effectiveness of probiotics against breast cancer. Early results are promising, but further studies in humans are necessary. ^{1 3 4 6 7}

Who Is on the Research Team?

Zahraa Al-Hilli, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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

You have abnormal lab results that could affect your participation in the study, as decided by the doctor.

I have a history of chronic digestive issues like IBD or ulcers.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Novel probiotic Experimental Treatment 1 Intervention

Investigational novel probiotic plus normal standard of care for breast cancer.

Group II: Placebo Placebo Group 1 Intervention

Placebo plus normal standard of care for breast cancer.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Probiotics in Cancer Prevention. Śliżewska, K., Markowiak-Kopeć, P., Śliżewska, W.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10004677/

Effect of Probiotics in Breast Cancer: A Systematic Review and ... Numerous in vitro and in vivo studies have demonstrated that probiotics can be effective at controlling growth of cancer cells [12,13]. Significant protective ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04362826

NCT04362826 | Study to Investigate Efficacy of a Novel ... The purpose of this study is to examine the effect of probiotics on the breast tumor microbiome and gut microbiome in breast cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0899900725003284?dgcid=rss_sd_all

A Novel Ally in Breast Cancer Combination Therapy Some probiotic strains also block cancer cell growth by promoting cancer cell apoptosis and reducing cell proliferation. Moreover, probiotics ...

4. nature.com nature.com/articles/s41522-025-00825-4

Optimizing breast cancer chemotherapy by harnessing gut ... Intestinal microbiota influences clinical outcome and side effects of early breast cancer treatment. ... novel probiotic Lactobacillus ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10972033/

Next-Generation Probiotics as Novel Therapeutics for ... However, it is important to note that more research is needed to establish the efficacy of probiotics in treating these cancers [69]. Carcinogenic and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04362826

NCT04362826 | Study to Investigate Efficacy of a Novel ... The purpose of this study is to examine the effect of probiotics on the breast tumor microbiome and gut microbiome in breast cancer.

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.00120/full

Microbiome and Breast Cancer: New Role for an Ancient ... The results showed that the probiotic Lactobacillus reuteri inhibited early-stage carcinogenesis and raised breast cell sensitivity to apoptosis (115).