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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT04362826
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Novel probiotic — BIOLOGICAL
    Investigational novel probiotic
  • Placebo — OTHER
    Placebo for probiotic

Study Details

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.

Key Dates

Start date
Mar 20, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Novel probiotic
    Investigational novel probiotic plus normal standard of care for breast cancer.
  • Placebo Comparator: Placebo
    Placebo plus normal standard of care for breast cancer.

Primary Outcome Measure

Beta-D-Glucagon levels [ Time Frame: At baseline and at 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterClevelandOhio44122
Charis Eng, MD
[email protected]
+1 216-444-3440
Charis Eng, MD, PhD, FACP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center· Cleveland, OH

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