NCT04857697

Effects of Probiotics on the Gut Microbiome and Immune System in Operable Stage I-III Breast or Lung Cancer

Engineering Gut Microbiome to Target Cancer-Immune Microenvironment in Breast and Lung Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Adenocarcinoma
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood, stool, and tissue samples
DRUG	Probiotic	Given PO
PROCEDURE	Therapeutic Conventional Surgery	Undergo standard of care surgery

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-03-08
• Completion: 2023-03-08
• First posted: 2021-04-23
• Last updated: 2023-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study