Probiotic BIOHM to change breast tumor and gut microbes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will enroll 100 women with invasive breast cancer and assign about half to take the probiotic BIOHM and half to take a placebo. Breast tissue and stool samples will be collected before and after the intervention to profile bacterial and fungal communities and polymicrobial biofilms. Quality of life questionnaires will be completed to compare symptoms and well-being between groups. The study aims to determine whether BIOHM produces measurable shifts in the bacteriome, mycobiome, and biofilm composition relative to placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female \> 18 years of age
* 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
* Agree to abstain from consuming unpasteurized bacteria-fermented foods one week prior to baseline visit and throughout the study (example list provided and reviewed during informed consent process).
* 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.

Where it's running

• Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Zahraa Al-Hilli, MD — Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
• Study coordinator: Zahraa Al-Hilli, MD
• Email: alhillz@ccf.org
• Phone: +1 216-444-3440

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.