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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Biological: Novel probiotic; Other: Placebo

Detailed Description

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 those receiving novel probiotic compared to placebo.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zahraa Al-Hilli, MD; Phone Number: +1 216-444-3440; Email: alhillz@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Recruiting
      • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
      • Contact: Charis Eng, MD; Phone Number: +1 216-444-3440; Email: engc@ccf.org
      • Principal Investigator: Charis Eng, MD, PhD, FACP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• BMI between 18.5 to 29.9 kg/m2
• Agree to abstain from consuming unpasteurized bacteria-fermented foods one week prior to baseline visit and throughout the study.
• Agree to not change current dietary habits (apart from avoiding probiotics) and activity/training levels one week prior to screening and during the study.
• Agree to complete all research activities defined in the study
• Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Women who are pregnant, breast feeding, or planning to become pregnant during the trial.
• Use of antibiotics within 5 weeks of randomization.
• History of chronic inflammation or structural abnormality of the digestive tract (e.g., inflammatory bowel disease, duodenal or gastric ulcer intestinal obstruction, or symptomatic cholelithiasis).
• Use of probiotic and/or prebiotic supplements and/or supplemented foods prior to screening and throughout the study.
• Individuals receiving any other investigational agents within 30 days prior to randomization.
• Change in anti-psychotic medication within 3 months prior to randomization.
• Alcohol or drug abuse in the past year.
• Participants with a known allergy to the test material's active or inactive ingredients..

Clinically significant abnormal laboratory results that may negatively impact the participant being involved on the study, at the discretion of the physician.

• 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.
• Physician feels participation in this trial is not in the subject's best interest.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel probiotic; Investigational novel probiotic plus normal standard of care for breast cancer.	Biological: Novel probiotic; Investigational novel probiotic
Placebo Comparator: Placebo; Placebo plus normal standard of care for breast cancer.	Other: Placebo; Placebo for probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beta-D-Glucagon levels	Efficacy of the novel probiotic as defined by change in Beta-D-Glucagon levels. This biomarker is well established to measure shifts in the mycobiome	At baseline and at 6 weeks
Short-chain fatty acid levels	Efficacy of the novel probiotic as defined by change in short-chain fatty acid levels. This biomarker is well established to measure shifts in the bacteriome	At baseline and at 6 weeks
Free amino acid levels	Efficacy of the novel probiotic as defined by change in free amino acid levels. This biomarker is well established to measure shifts in the bacteriome	At baseline and at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alpha and beta biodiversity of gut microbiome and mycobiome	Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by alpha and beta biodiversity	At baseline and at 6 weeks
Differential abundances of gut microbiome and mycobiome	Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by differential abundances	At baseline and at 6 weeks
Polymicrobial biofilm composition of gut microbiome and mycobiome	Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by polymicrobioal biofilm composition	At baseline and at 6 weeks
Alpha and beta biodiversity of breast microbiome and mycobiome	Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by alpha and beta biodiversity	At baseline and at 6 weeks
Differential abundances of breast microbiome and mycobiome	Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by differential abundances	At baseline and at 6 weeks
Polymicrobial biofilm composition of breast microbiome and mycobiome	Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by polymicrobioal biofilm composition	At baseline and at 6 weeks
QoL via standardized European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30	Quality of life (QoL) via EORTC QLQ C-30 will be converted into dimensions, which evaluate the quality of life associated with health. Dimensions are expected to range 0-100, with high scores referring to higher responses (QoL, symptoms) and are described by the arithmetic mean and standard deviation. Mann-Whitney U test will be utilized to compare the dimensions between each of the 2 groups (probiotic vs placebo groups). For testing the statistical significance of the change in dimensions before and after treatment (within probiotic arm; within placebo arm), the Wilcoxon signed rank test will be used. P<0.05 will be considered statistically significant.	At baseline and at 6 weeks
QoL via EORTC QLQ-BR23	EORTC QLQ-BR23 will be converted into dimensions, which evaluate the quality of life associated with health. Dimensions are expected to range 0-100 with high scores referring to higher responses (QoL, symptoms) and are described by the arithmetic mean and standard deviation. Mann-Whitney U test will be utilized to compare the dimensions between each of the 2 groups (probiotic vs placebo groups). For testing the statistical significance of the change in dimensions before and after treatment (within probiotic arm; within placebo arm), the Wilcoxon signed rank test will be used. P<0.05 will be considered statistically significant.	At baseline and at 6 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Zahraa Al-Hilli, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CASE13119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No