RecruitingEarly Phase 1NCT07144826

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

A Randomized, Double-Blind, Placebo Controlled, Study to Investigate Efficacy of a Probiotic Intervention on the Gut and Vaginal Microbiome of Ovarian Cancer Patients Undergoing Treatment With Platinum Chemotherapy


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

161 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a specific probiotic supplement can improve the balance of bacteria in the gut and vagina in women with advanced or recurrent ovarian cancer who are receiving platinum-based chemotherapy (a common cancer treatment). Researchers want to see if improving the microbiome helps reduce side effects or improves outcomes. **You may be eligible if...** - You are 18 years or older - You have advanced (stage II–IV) or recurrent ovarian cancer and will be receiving platinum-based chemotherapy as standard care - You are willing to avoid other probiotic or prebiotic supplements during the study - You agree not to make major dietary changes during the study **You may NOT be eligible if...** - You have a borderline (low-grade) ovarian tumor - You have a prior allergy or intolerance to probiotic products - You have chronic inflammation or structural problems in your digestive tract (e.g., inflammatory bowel disease requiring medication, active ulcers, bowel obstruction) - Your blood counts are too low to safely receive platinum chemotherapy - You have a known allergy to any ingredient in the study probiotic product or to multiple antibiotics that target the bacterial strains used Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood and vaginal sample collection

DRUGPlacebo Administration

Given PO

DIETARY_SUPPLEMENTProbiotic

Given PO

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT07144826


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