Probiotic support for gut and vaginal microbiome during platinum chemotherapy for advanced or recurrent ovarian cancer
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
EARLY_PHASE1 · Ohio State University Comprehensive Cancer Center · NCT07144826
This trial will test whether taking a probiotic during platinum chemotherapy helps keep the gut and vaginal microbiome healthier and may improve symptoms, quality of life, or cancer outcomes for people with advanced or recurrent ovarian cancer.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 161 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07144826 on ClinicalTrials.gov |
What this trial studies
Participants with advanced or recurrent ovarian cancer will be randomized to receive either an oral probiotic or a placebo while undergoing standard platinum-based chemotherapy. The study collects stool and vaginal samples over time to compare changes in microbial composition between groups, and uses questionnaires (including a food frequency questionnaire and quality-of-life measures) to capture diet, symptoms, and patient experience. Secondary and exploratory measures include compliance with the interventions and sample collections, chemotherapy toxicity, stool consistency, serum metabolomic and immune markers, and clinical outcomes such as recurrence-free and overall survival. The trial is single-center and integrates biospecimen and clinical data to link microbiome changes with patient-reported and clinical endpoints.
Who should consider this trial
Good fit: Adults (age 18 or older) with stage II-IV or recurrent ovarian cancer who will receive platinum-based chemotherapy, can consent, and agree to avoid other probiotic/prebiotic supplements and major diet changes during the study are eligible.
Not a fit: Patients with borderline ovarian tumors, known allergy or intolerance to probiotic products, those not receiving platinum chemotherapy, or those unable to comply with the no-other-probiotic and diet-stability requirements are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the probiotic could help maintain a healthier gut and vaginal microbiome during chemotherapy, potentially reducing gastrointestinal side effects, improving quality of life, and possibly affecting cancer outcomes.
How similar studies have performed: Small clinical and preclinical studies have shown that probiotics can alter the gut microbiome and sometimes reduce gastrointestinal side effects during cancer therapy, but robust evidence in ovarian cancer and clear effects on long-term oncologic outcomes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to understand and willingness to sign a written consent form. In patients who do not speak English, ability to have informed consent form translated in their native language and have their native language translator present for consenting process * Age \> 18 years old * Patient with advanced (stage II, III or IV) or recurrent ovarian cancer who will receive platinum-based chemotherapy as standard of care (cisplatin, carboplatin containing regimens) * Agreeable to participate in all research activities defined in the study * Agreeable to not take any other probiotic and/or prebiotic supplements outside of study intervention during the study * Agreeable to not make significant changes to their diet throughout the course of the study * Patients with ileostomy, colostomy are permitted to participate Exclusion Criteria: * Borderline ovarian tumors * Prior allergy or food intolerance to any probiotic product * History of chronic inflammation or active structural abnormality of the digestive tract (e.g., inflammatory bowel disease requiring medications, active duodenal or gastric ulcer, complete large or small bowel intestinal obstruction, active fistula) * Patients who do not meet laboratory parameters for platinum-based chemotherapy, including absolute neutrophil count (ANC) \< 1500 * Known hypersensitivity to any component of study product (Akkermansia muciniphila, Anaerobutyricum hallii, Clostridium beijerinckii, Clostridium butyricum and Bifidobacterium infantis, chicory inulin, magnesium stearate, grape food color, and silica) * Known hypersensitivity to \> 4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: penicillin, piperacillin, tetracycline, amoxicillin, ampicillin * Known hypersensitivity to \> 4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26\^Trademark (TM): gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Laura Chambers, DO — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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