Recruiting
Early Phase 1

Probiotic Intervention

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07144826

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

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Placebo Administration

Probiotic

Questionnaire Administration

Study Details

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 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

Advanced Ovarian Carcinoma

Recurrent Ovarian Carcinoma

Stage II Ovarian Cancer AJCC v8

Stage III Ovarian Cancer AJCC v8

Stage IV Ovarian Cancer AJCC v8

Study ID

NCT07144826

Start date

Mar 6, 2026

Status verified date

Aug, 2026

Completion date

Jul 9, 2027

Anticipated

Primary completion date

Jul 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

161 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (probiotic)

Patients receive probiotic PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study.

placebo comparator: Arm II (placebo)

Patients receive placebo PO BID beginning within seven days of SOC platinum chemotherapy cycle 1 until seven days after their cycle 6. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and vaginal sample collection throughout the study.

Interventions

Biospecimen Collection

Undergo blood and vaginal sample collection

Placebo Administration

Given PO

Probiotic

Given PO

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Changes to the gut microbiome composition [ Time Frame: Within one week before or after cycle 1 of chemotherapy, within one week before or after cycle 3 of adjuvant chemotherapy, and within one week before or after cycle 6 of adjuvant chemotherapy (cycle length = 21 days) ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Laura Chambers, DO

614-293-7642laura.chambers@osumc.edu

Principal Investigator:

Laura Chambers, DO

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-08-17.