Probiotic BIOHM to change breast tumor and gut microbes
A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients
This trial will test whether taking the probiotic BIOHM can change the bacteria and fungi in the breast tumor and gut of women with breast cancer compared with a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04362826 on ClinicalTrials.gov |
What this trial studies
This interventional study will enroll 100 women with invasive breast cancer and assign about half to take the probiotic BIOHM and half to take a placebo. Breast tissue and stool samples will be collected before and after the intervention to profile bacterial and fungal communities and polymicrobial biofilms. Quality of life questionnaires will be completed to compare symptoms and well-being between groups. The study aims to determine whether BIOHM produces measurable shifts in the bacteriome, mycobiome, and biofilm composition relative to placebo.
Who should consider this trial
Good fit: Women with invasive ductal or lobular breast cancer with a tumor at least 1.0 cm, BMI 18.5–29.9 kg/m2, not pregnant or breastfeeding, and willing to avoid other probiotics and recent antibiotics are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, have used antibiotics within the required washout period, have tumors smaller than 1.0 cm, or cannot follow the dietary and medication restrictions are unlikely to join or benefit from this study.
Why it matters
Potential benefit: If successful, the probiotic could offer a safe, noninvasive way to modify tumor and gut microbes that might inform new prevention, diagnostic, or supportive approaches for breast cancer patients.
How similar studies have performed: Prior probiotic studies have produced mixed and preliminary results for the gut microbiome, and direct targeting of the breast tumor microbiome remains relatively novel with limited clinical evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Zahraa Al-Hilli, MD — Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
- Study coordinator: Zahraa Al-Hilli, MD
- Email: alhillz@ccf.org
- Phone: +1 216-444-3440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.