Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
NCT04362826

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

Led by Case Comprehensive Cancer Center · Updated on 2026-04-09

100

Participants Needed

1

Research Sites

36 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of breast cancer (invasive ductal carcinoma [IDC] or Invasive Lobular Carcinoma [ILC])
  • Minimum breast tumor size of 1.0 cm
  • Participants of childbearing potential must use medically approved birth control and have a negative pregnancy test
  • BMI between 18.5 to 29.9 kg/m2
  • Agree to avoid unpasteurized bacteria-fermented foods one week before baseline and during the study
  • Agree not to change diet (except avoiding probiotics) and activity levels one week before screening and during the study
  • Agree to complete all research activities
  • Ability and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or planning pregnancy during the trial
  • Use of antibiotics within 5 weeks before randomization
  • History of chronic inflammation or digestive tract abnormalities (e.g., inflammatory bowel disease, ulcers, intestinal obstruction, symptomatic gallstones)
  • Use of probiotic or prebiotic supplements or supplemented foods before screening and during the study
  • Use of other investigational agents within 30 days before randomization
  • Change in antipsychotic medication within 3 months before randomization
  • Alcohol or drug abuse in the past year
  • Known allergy to any ingredients of the test material
  • Clinically significant abnormal lab results affecting study participation
  • Any condition that may impair ability to complete study or pose risk, as judged by the physician
  • Physician determines participation is not in the participant's best interest

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44122

Actively Recruiting

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Research Team

Z

Zahraa Al-Hilli, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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