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RECRUITING

NCT07144826

EARLY_PHASE1

Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy

Sponsor: Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

161

Start Date

2026-03-09

Completion Date

2027-07-09

Last Updated

2026-02-13

Healthy Volunteers

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and vaginal sample collection

DRUG

Placebo Administration

Given PO

DIETARY_SUPPLEMENT

Probiotic

Given PO

OTHER

Questionnaire Administration

Ancillary studies

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

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States