Clinical trial NCT04362826: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Primary outcomes:
measure: Beta-D-Glucagon levels
timeFrame: At baseline and at 6 weeks
measure: Short-chain fatty acid levels
timeFrame: At baseline and at 6 weeks
measure: Free amino acid levels
timeFrame: At baseline and at 6 weeks
Secondary outcomes:
measure: Alpha and beta biodiversity of gut microbiome and mycobiome
timeFrame: At baseline and at 6 weeks
measure: Differential abundances of gut microbiome and mycobiome
timeFrame: At baseline and at 6 weeks
measure: Polymicrobial biofilm composition of gut microbiome and mycobiome
timeFrame: At baseline and at 6 weeks
measure: Alpha and beta biodiversity of breast microbiome and mycobiome
timeFrame: At baseline and at 6 weeks
measure: Differential abundances of breast microbiome and mycobiome
timeFrame: At baseline and at 6 weeks
measure: Polymicrobial biofilm composition of breast microbiome and mycobiome
timeFrame: At baseline and at 6 weeks
measure: QoL via standardized European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
timeFrame: At baseline and at 6 weeks
measure: QoL via EORTC QLQ-BR23
timeFrame: At baseline and at 6 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Zahraa Al-Hilli, MD
role: PRINCIPAL_INVESTIGATOR
References: