RecruitingNot ApplicableNCT04362826

Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer

A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients

Sponsor

Case Comprehensive Cancer Center

Enrollment

100 participants

Start Date

Mar 20, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether a probiotic supplement called BIOHM — which aims to balance both bacteria and fungi in the gut — can alter the microbiome of breast cancer patients and potentially improve their quality of life. Emerging research suggests that the mix of microorganisms in the gut and breast tissue may play a role in cancer development, and this study aims to understand that connection. Eligible participants are women with confirmed invasive ductal or lobular breast cancer, a tumor of at least 1 cm, a BMI between 18.5 and 29.9 kg/m², who are not pregnant, have not recently taken antibiotics, and agree to avoid other probiotic products during the study. Participation involves being randomly assigned to take BIOHM or a placebo capsule daily, providing stool samples and breast tissue samples at the start and end of the study, and completing quality of life questionnaires. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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