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

Launched by CASE COMPREHENSIVE CANCER CENTER · Apr 23, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special type of probiotic called BIOHM can help improve the balance of microorganisms in the breast tissue and gut of women with breast cancer. Researchers believe that these microorganisms may play a role in how breast cancer develops, and by understanding this relationship better, they hope to find new ways to prevent, diagnose, and treat the disease.

To be eligible for the study, participants must be women diagnosed with invasive breast cancer, have a minimum tumor size of 1.0 cm, and meet certain health criteria, such as a specific body mass index (BMI). Participants will need to avoid certain foods and supplements during the study and agree to complete all research activities. While the study is not yet recruiting, those who take part can expect to help advance our understanding of breast cancer and the potential benefits of probiotics. It's important to note that women who are pregnant or breastfeeding, or those with certain health conditions, will not be eligible to participate.

Gender

FEMALE

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.