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Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy

NCT07144826 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2026-02-13

No results posted yet for this study

Summary

This clinical trial evaluates the effects a probiotic intervention has on the gut and vaginal microbiome in patients undergoing chemotherapy for ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Gut health is also known as the gut microbiome. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. Probiotics are dietary supplements containing live microorganisms that may help keep the gastrointestinal tract healthy. A probiotic intervention during platinum chemotherapy in ovarian cancer patients may impact the gut and vaginal microbiota, quality of life, symptoms, and oncologic outcomes.

Conditions

  • Advanced Ovarian Carcinoma
  • Recurrent Ovarian Carcinoma
  • Stage II Ovarian Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and vaginal sample collection

DRUG

Placebo Administration

Given PO

DIETARY_SUPPLEMENT

Probiotic

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • Ovarian Cancer Research Alliance

    collaborator UNKNOWN

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Laura Chambers, DO · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2027-07-09
Completion
2027-07-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144826 on ClinicalTrials.gov