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

A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how BIOHM, a probiotic food supplement, affects bacteria, fungi, and other tiny organisms in breast tumors and the gut. It is for women older than 18 with certain types of breast cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a woman older than 18.
  • Have invasive ductal or invasive lobular breast cancer, which starts in milk ducts or milk-making glands and spreads into nearby tissue.
  • Have a breast tumor at least 1 centimeter wide.
  • If you can become pregnant, agree to use medically approved birth control and have a negative pregnancy test.
  • Avoid unpasteurized foods fermented with bacteria from one week before the first study visit through the study. These foods have not been heat-treated to kill germs.
  • Keep your usual diet, except for avoiding probiotics, and activity levels from one week before screening through the study.
  • Agree to complete all study activities.
  • Be able to understand and willing to sign the study consent form.

Who can't join

  • Be pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have used antibiotics within 5 weeks before assignment to a study group, or another experimental treatment within 30 days before assignment.
  • Have a history of long-term swelling or damage in the digestive tract, such as bowel inflammation, stomach or intestinal ulcers, a blocked intestine, or gallstones causing symptoms.
  • Use probiotic or prebiotic supplements or foods with these added before screening or during the study. These products contain or feed helpful germs.
  • Have changed antipsychotic medicine, used for some mental health conditions, within 3 months before assignment to a study group.
  • Have abused alcohol or drugs in the past year.
  • Have a known allergy to any ingredient in the study supplement.
  • Have abnormal lab results or another condition that the study doctor believes could make participation unsafe or prevent study completion, or the doctor feels joining is not in your best interest.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

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