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

Official title

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

Overview

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.

Detailed description

This study will investigate the efficacy of the investigational product (a novel probiotic) on altering the microbiome (bacteriomeand mycobiome) and polymicrobial biofilms in the gut of 50 women with breast cancer given the novel probiotic, compared to 50 women with breast cancer given a placebo.

The objectives of this study are to:

1. Determine the efficacy profile of the novel probiotic 2. Analyze bacteriome and mycobiome profiles as well as polymicrobial biofilm composition from breast tissue and stool before and after consumption of the probiotic. 3. Compare quality of life (QoL) of those receiving novel probiotic compared to placebo.

Interventions

• Biological Novel probiotic
  Investigational novel probiotic
• Other Placebo
  Placebo for probiotic

Primary outcome measures

• Beta-D-Glucagon levels [Time frame: At baseline and at 6 weeks]
• Short-chain fatty acid levels [Time frame: At baseline and at 6 weeks]
• Free amino acid levels [Time frame: At baseline and at 6 weeks]

Secondary outcome measures (8)

• Alpha and beta biodiversity of gut microbiome and mycobiome [Time frame: At baseline and at 6 weeks]
• Differential abundances of gut microbiome and mycobiome [Time frame: At baseline and at 6 weeks]
• Polymicrobial biofilm composition of gut microbiome and mycobiome [Time frame: At baseline and at 6 weeks]
• Alpha and beta biodiversity of breast microbiome and mycobiome [Time frame: At baseline and at 6 weeks]
• Differential abundances of breast microbiome and mycobiome [Time frame: At baseline and at 6 weeks]
• Polymicrobial biofilm composition of breast microbiome and mycobiome [Time frame: At baseline and at 6 weeks]
• QoL via standardized European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 [Time frame: At baseline and at 6 weeks]
• QoL via EORTC QLQ-BR23 [Time frame: At baseline and at 6 weeks]

Eligibility criteria

Inclusion criteria

• 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center — Cleveland

Identifiers

NCT: NCT04362826 · CASE13119

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗