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

NCT04362826 | Recruiting

• 1 other identifier: CASE13119
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Alpha and beta biodiversity of gut microbiome and mycobiome

  At baseline and at 6 weeks

• Differential abundances of gut microbiome and mycobiome

  At baseline and at 6 weeks

• Polymicrobial biofilm composition of gut microbiome and mycobiome

  At baseline and at 6 weeks

• Alpha and beta biodiversity of breast microbiome and mycobiome

  At baseline and at 6 weeks

• Differential abundances of breast microbiome and mycobiome

  At baseline and at 6 weeks

Study Arms (2)

Novel probiotic

EXPERIMENTAL

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

Biological: Novel probiotic

Placebo

PLACEBO COMPARATOR

Placebo plus normal standard of care for breast cancer.

Other: Placebo

Interventions

Novel probiotic BIOLOGICAL

Investigational novel probiotic

Novel probiotic

Placebo OTHER

Placebo for probiotic

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44122, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zahraa Al-Hilli, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahraa Al-Hilli, MD

CONTACT

+1 216-444-3440; alhillz@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: March 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)