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

Primary Purpose

Breast Cancer

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Novel probiotic

Placebo

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Novel probiotic

Placebo

Arm Description

Investigational novel probiotic plus normal standard of care for breast cancer.

Placebo plus normal standard of care for breast cancer.

Outcomes

Primary Outcome Measures

Beta-D-Glucagon levels

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 levels

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 levels

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

Secondary Outcome Measures

Alpha and beta biodiversity of gut microbiome and mycobiome

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by alpha and beta biodiversity

Differential abundances of gut microbiome and mycobiome

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by differential abundances

Polymicrobial biofilm composition of gut microbiome and mycobiome

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by polymicrobioal biofilm composition

Alpha and beta biodiversity of breast microbiome and mycobiome

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by alpha and beta biodiversity

Differential abundances of breast microbiome and mycobiome

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by differential abundances

Polymicrobial biofilm composition of breast microbiome and mycobiome

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by polymicrobioal biofilm composition

QoL via standardized European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

Quality of life (QoL) via EORTC QLQ C-30 will be converted into dimensions, which evaluate the quality of life associated with health. Dimensions are expected to range 0-100, with high scores referring to higher responses (QoL, symptoms) and are described by the arithmetic mean and standard deviation. Mann-Whitney U test will be utilized to compare the dimensions between each of the 2 groups (probiotic vs placebo groups). For testing the statistical significance of the change in dimensions before and after treatment (within probiotic arm; within placebo arm), the Wilcoxon signed rank test will be used. P<0.05 will be considered statistically significant.

QoL via EORTC QLQ-BR23

EORTC QLQ-BR23 will be converted into dimensions, which evaluate the quality of life associated with health. Dimensions are expected to range 0-100 with high scores referring to higher responses (QoL, symptoms) and are described by the arithmetic mean and standard deviation. Mann-Whitney U test will be utilized to compare the dimensions between each of the 2 groups (probiotic vs placebo groups). For testing the statistical significance of the change in dimensions before and after treatment (within probiotic arm; within placebo arm), the Wilcoxon signed rank test will be used. P<0.05 will be considered statistically significant.

Full Information

NCT ID

NCT04362826

First Posted

April 23, 2020

Last Updated

July 11, 2023

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04362826

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Novel probiotic

Arm Type

Experimental

Arm Description

Investigational novel probiotic plus normal standard of care for breast cancer.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo plus normal standard of care for breast cancer.

Intervention Type

Biological

Intervention Name(s)

Novel probiotic

Intervention Description

Investigational novel probiotic

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo for probiotic

Primary Outcome Measure Information:

Title

Beta-D-Glucagon levels

Description

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

Time Frame

At baseline and at 6 weeks

Title

Short-chain fatty acid levels

Description

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

Time Frame

At baseline and at 6 weeks

Title

Free amino acid levels

Description

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

Time Frame

At baseline and at 6 weeks

Secondary Outcome Measure Information:

Title

Alpha and beta biodiversity of gut microbiome and mycobiome

Description

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by alpha and beta biodiversity

Time Frame

At baseline and at 6 weeks

Title

Differential abundances of gut microbiome and mycobiome

Description

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by differential abundances

Time Frame

At baseline and at 6 weeks

Title

Polymicrobial biofilm composition of gut microbiome and mycobiome

Description

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in stool as measured by polymicrobioal biofilm composition

Time Frame

At baseline and at 6 weeks

Title

Alpha and beta biodiversity of breast microbiome and mycobiome

Description

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by alpha and beta biodiversity

Time Frame

At baseline and at 6 weeks

Title

Differential abundances of breast microbiome and mycobiome

Description

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by differential abundances

Time Frame

At baseline and at 6 weeks

Title

Polymicrobial biofilm composition of breast microbiome and mycobiome

Description

Gut microbiome and polymicrobioal biofilm composition analyzed through bacteriome in breast tissue as measured by polymicrobioal biofilm composition

Time Frame

At baseline and at 6 weeks

Title

QoL via standardized European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

Description

Time Frame

At baseline and at 6 weeks

Title

QoL via EORTC QLQ-BR23

Description

Time Frame

At baseline and at 6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zahraa Al-Hilli, MD

Phone

+1 216-444-3440

alhillz@ccf.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zahraa Al-Hilli, MD

Organizational Affiliation

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charis Eng, MD

Phone

+1 216-444-3440

engc@ccf.org

First Name & Middle Initial & Last Name & Degree

Charis Eng, MD, PhD, FACP

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All IPD that underlie results in publication

Learn more about this trial

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

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