NCT07144826RecruitingEarly phase 1
Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy
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
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 161 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- 6 Mar 2026
- Primary completion date
- 9 Jul 2027
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Diseases
- Ovarian cancer
- NCT number
- NCT07144826
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 161
- From 6 Mar 2026 to the primary completion date, 9 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allergy or food intolerance to any probiotic product
Other illness
- 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)
- 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
Lab values
- 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)
Other
- Borderline ovarian tumors
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.