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Probiotic Study for Breast Cancer and the Microbiome

This study is looking at how a probiotic called BIOHM might affect the bacteria and fungi (microbiome) in your gut and breast tissue if you have breast cancer. Researchers believe these tiny organisms might play a role in breast cancer development. You could be eligible if you are a woman between 18 and 65 years old with invasive ductal carcinoma (IDC) or invasive lobular carcinoma (ILC) breast cancer, with a tumor at least 1.0 cm. The study aims to see if BIOHM can change these microbiomes and potentially improve your quality of life. Half of the participants will receive BIOHM, and the other half will receive a placebo (an inactive substance). We are currently unclear on the recruitment status for this study.

Study design
This interventional study will involve 100 women with breast cancer, with 50 receiving the novel probiotic BIOHM and 50 receiving a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your Beta-D-Glucagon, short-chain fatty acid, and free amino acid levels will be measured at the beginning of the study and again at 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04362826

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

Recruiting
NAAges 18–65InterventionalSupportive care
Case Comprehensive Cancer Center
~100 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Novel probioticPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Beta-D-Glucagon levels
Measured over At baseline and at 6 weeks
+2 more outcomes measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Zahraa Al-Hilli, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Who to contact

Zahraa Al-Hilli, MD
[email protected]
+1 216-444-3440
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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..
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.

What this trial measures

  • Beta-D-Glucagon levelsAt baseline and at 6 weeks

    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

  • Short-chain fatty acid levelsAt baseline and at 6 weeks

    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

  • Free amino acid levelsAt baseline and at 6 weeks

    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