Status:
NOT_YET_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
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Advanced Ovarian Carcinoma
Recurrent Ovarian Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate changes to the gut microbiome composition in ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy. SECONDARY O...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 9 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 9 2027
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT07144826
Start Date
January 9 2026
End Date
July 9 2027
Last Update
November 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210