Actively Recruiting
Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-02-13
161
Participants Needed
1
Research Sites
69 weeks
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 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
Official 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 willing to sign informed consent (with translator if needed)
- Age over 18 years old
- Diagnosis of advanced (stage II, III, or IV) or recurrent ovarian cancer
- Scheduled to receive platinum-based chemotherapy as standard treatment
- Willing to participate in all study activities
- Agree not to take other probiotic or prebiotic supplements outside the study during participation
- Agree not to make major diet changes during the study
- Patients with ileostomy or colostomy allowed to participate
You will not qualify if you...
- Borderline ovarian tumors
- Allergy or intolerance to any probiotic product
- History of chronic inflammation or active structural problems in the digestive tract (such as inflammatory bowel disease needing medication, active ulcers, bowel obstruction, or fistula)
- Not meeting lab requirements for platinum chemotherapy, including absolute neutrophil count below 1500
- Known allergy to any ingredient in the study probiotic product
- Known allergy to more than four first-line antibiotics targeting specific probiotic bacteria strains
AI-Screening
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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
CONTACT
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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