NCT07144826 · Ohio State University Comprehensive Cancer Center
Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy
What this study is about
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.
View original scientific description
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.
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
Primary outcome measures
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)
Will be assessed by stool samples collected from all patients. Microbe diversity and communities are assessed by 16s ribosomal ribonucleic acid sequencing and metagenomic whole-genome shotgun sequencing. Presence of microbes between responders and non-responders will be compared using Fisher's exact tests and logistic regression. Changes over time will be assessed using generalized linear or logistic regression models accounting for repeated measures, depending on the format of the outcome variable.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Columbus, Ohio
Collaborators
Doris Duke Charitable Foundation, Ovarian Cancer Research Alliance, United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations