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

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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedBiopsy and Biospecimen Collection

Plus 2 other study approaches.

Who it may be forEarly-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 21, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Early Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Mayo Clinic

Study sponsor

Study overview

What this study is about

Purpose: Supportive Care
Study type: Interventional
Phase: Early Phase 1
Sponsor: Mayo Clinic
Interventions being studied: Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Probiotic; Procedure: Therapeutic Conventional Surgery

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Early-stage or resectable→Locally advanced→

Treatment approach

Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

\>= 18 years of age
Histologically confirmed adenocarcinoma of the breast operable stage I-III or histologically confirmed carcinoma of the lung operable stage I-III will be enrolled prior to their definitive surgery
Patients must have adequate organ function
Patients must be willing to provide tissue, blood and stool samples for the research study

Reasons someone may not be able to joinExclusion criteria

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mayo Clinic in FloridaJacksonville, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 21, 2023. Always confirm current availability with the study team.

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