Actively Recruiting
A Randomized, Double-Blind, Placebo Controlled Study to Investigate the Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Women With Advanced or Recurrent Ovarian Cancer Undergoing Platinum Chemotherapy
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-02-13
161
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ohio State University Comprehensive Cancer Center
Lead Sponsor
D
Doris Duke Charitable Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study the effects of a probiotic intervention on the gut and vaginal microbiome in women with advanced or recurrent ovarian cancer undergoing platinum-based chemotherapy. It evaluates how probiotics may influence the bacteria and organisms in the digestive and vaginal tracts, quality of life, symptoms, and cancer-related outcomes during treatment. The study is an early phase clinical trial sponsored by a cancer research center. Participants are randomly assigned to one of two groups: one receives a probiotic supplement by mouth twice daily starting within seven days of the first chemotherapy cycle and continuing until seven days after the sixth cycle, while the other group receives a placebo on the same schedule. Each chemotherapy cycle lasts 21 days, with up to six cycles planned if there is no disease progression or significant toxicity. Throughout the study, blood and vaginal samples are collected to analyze microbiome changes. During the study, participants will have stool and vaginal microbiome samples collected before or after chemotherapy cycles 1, 3, and 6 to assess changes in microbiome composition. Researchers will monitor patient compliance with taking supplements and sample collections, record survival outcomes, and evaluate quality of life, chemotherapy side effects, and immune markers. The study also includes questionnaires about diet and tracks surgical and infection outcomes if applicable. Participation can last through the chemotherapy cycles and follow-up periods as defined.
CONDITIONS
Brief Title
Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingly sign a written consent form
- Age over 18 years old
- Diagnosis of advanced (stage II, III, or IV) or recurrent ovarian cancer
- Scheduled to receive platinum-based chemotherapy (cisplatin or carboplatin regimens) as standard care
- Willing to participate in all defined research activities
- Agree not to take other probiotic or prebiotic supplements during the study
- Agree not to make significant diet changes during the study
- Patients with ileostomy or colostomy are allowed to participate
You will not qualify if you...
- Diagnosis of borderline ovarian tumors
- Allergy or intolerance to any probiotic product
- History of chronic inflammation or active structural digestive tract issues requiring medication (e.g., inflammatory bowel disease, active ulcers, bowel obstruction, fistula)
- Not meeting laboratory requirements for platinum chemotherapy, including absolute neutrophil count below 1500
- Known allergy to any component of the study probiotic product
- Known allergy to multiple first-line antibiotics effective against probiotic bacteria (specific antibiotics listed)
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 21 days each plus 7 days after the last cycle)
Participants receive probiotic or placebo orally twice daily starting within seven days of their first platinum chemotherapy cycle and continuing until seven days after their sixth cycle. Chemotherapy cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Blood and vaginal samples are collected throughout this period.
Visits aligned with each chemotherapy cycle (up to 6 cycles)
Duration - Months from first chemotherapy cycle until recurrence or death
Participants are monitored over months following treatment to assess recurrence-free survival and overall survival.
Visits scheduled per physician assessment during follow-up period
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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