CompletedEarly Phase 1NCT04857697

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

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.

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

StatusCompleted
PhaseEarly Phase 1
U.S. locations1
SponsorMayo Clinic
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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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion 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.

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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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