This clinical trial evaluates whether engineering gut microbiome using probiotics will alter the body’s immune system to react to stage I-III breast or lung cancers that can be removed by surgery (operable). Having diverse species of bacteria inside the bowel may help improve the immune system, particularly the ability of the immune system to recognize cancer. Taking probiotics may change the diversity and make up of the bacteria in the bowels, and change how the immune system reacts to breast or lung cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04857697.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To conduct a pilot study of probiotics prior to surgery in operable breast and lung cancer patients.
II. To evaluate systemic and intratumoral immunomodulatory effects of probiotics in operable breast and lung cancer patients.
OUTLINE:
Patients undergo collection of blood samples at baseline and time of surgery, and collection of stool samples at baseline and after completion of probiotic regimen. Patients receive probiotics orally (PO) once on day 1, and then twice daily (BID) or three times daily (TID) for 2-4 weeks before standard of care surgery. Patients also undergo collection of tissue samples during standard of care surgery.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMayo Clinic in Florida
Principal InvestigatorSaranya Chumsri
