Probiotic support for gut and vaginal microbiome during platinum chemotherapy for advanced or recurrent ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.