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

Phase

Condition

Breast Cancer

Adenocarcinoma

Treatment

N/A

Clinical Study ID

NCT04857697

MC210302

NCI-2021-03139

20-011177

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

>= 18 years of age
Histologically confirmed adenocarcinoma of the breast operable stage I-III orhistologically confirmed carcinoma of the lung operable stage I-III will be enrolledprior to their definitive surgery
Patients must have adequate organ function
Patients must be willing to provide tissue, blood and stool samples for the researchstudy

Exclusion

Exclusion Criteria:

Patients must not receive systemic neoadjuvant therapy
Patients must not have taken any probiotics in the past 30 days prior to theenrollment
Patients with autoimmune disease, immune deficiency such as human immunodeficiencyvirus (HIV), irritable bowel, known diverticulosis, and other serious gastrointestinal (GI) conditions at treating physician's discretion will be excluded

Study Design

July 01, 2021

March 08, 2023

Study 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.

Connect with a study center

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.