Clinical Trial

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

Recruiting Early Phase 1
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-20; most recent amendment 2026-06-16.
Status change: Not Yet Recruiting → Recruiting 2026-02-11
Trial Details
NCT Number NCT07144826
Lead Sponsor Ohio State University Comprehensive Cancer Center
Collaborators: Doris Duke Charitable Foundation, Ovarian Cancer Research Alliance, United States Department of Defense
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
Enrollment 161 participants
Start Date 2026-03-06
Primary Completion 2027-07-09 (estimated)
Study Completion 2027-07-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-18