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NCT04857697 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study, sponsored by Mayo Clinic.

Completed
Registry status
Early Phase 1
Development phase
6
Enrollment target

NCT04857697: Completed Early Phase 1 study, sponsored by Mayo Clinic.

NCT04857697 is a Early Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT04857697, a Early Phase 1 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Early Phase 1
Development phase
6 participants
Enrollment target

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.

Primary Outcome

Will be collected via study diaries.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Biopsy
  • PROCEDURE Therapeutic Conventional Surgery
  • DRUG Probiotic

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2021-07-01
Est. Completion 2023-03-08
Phase Early Phase 1
Mayo Clinic

2,844 total trials

What the finished NCT04857697 record still lists

NCT04857697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 4 interventions - of which Biospecimen Collection is the first listed.

NCT04857697 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04857697 about?

NCT04857697 is a clinical study titled "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, part...

What is the current status of trial NCT04857697?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2021-07-01. Estimated completion is 2023-03-08.

What interventions are being tested in trial NCT04857697?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Therapeutic Conventional Surgery (PROCEDURE), Probiotic (DRUG).

Who is sponsoring clinical trial NCT04857697?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04857697's enrollment target sits among peer trials

6 1846th of 2000 higher than 114 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04857697, the US trial registry maintained by the National Library of Medicine. NCT04857697 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.