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Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy

RecruitingObservational study

Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy

Who can join

Ages 18 and older · Women

Full eligibility criteria
Inclusion Criteria:

* Adult females \> 18 years old
* Advanced or recurrent gynecological cancer patients from AHMG Advent Health Orlando Gynecologic Oncology Group
* Patients for whom an immunotherapy regimen has been ordered

Exclusion Criteria:

* Patients unable to provide fecal specimens at three time points
* Patients unable to read or understand informed consent
* Taking medications that may affect gut microbiome:

  * Proton pump inhibitors (PPIs)
  * Metformin
  * Antibiotics
  * Laxatives
* Patients who are receiving investigational agent

About the study

30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.

Sponsor: Viome · Participants: 30 · Started: Jun 29, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04957511

Locations in the U.S.

FloridaAdventHealth Cancer Institute, Orlando

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.