Status:
NOT_YET_RECRUITING
Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
NA
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, bacter...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04362826
Start Date
February 1 2026
End Date
December 1 2026
Last Update
December 24 2025
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44122