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Probiotic Intervention for Ovarian Cancer Patients Undergoing Chemotherapy

This study is looking at how a probiotic (a dietary supplement with live microorganisms that may help keep your gut healthy) affects the gut and vaginal microbiome (the collection of bacteria and other organisms) in women with advanced or recurrent ovarian cancer. These women will be receiving platinum chemotherapy. Researchers want to see if taking a probiotic during chemotherapy changes the balance of these microorganisms. You would either receive the probiotic or a placebo (an inactive substance that looks like the probiotic). The study aims to enroll 161 women aged 18 and older who have advanced (Stage II, III, or IV) or recurrent ovarian cancer and are starting platinum chemotherapy.

Study design
This is an interventional study planning to enroll 161 participants. Participants will be randomized to receive either a probiotic or a placebo.
What's involved
You would provide blood and vaginal samples and complete questionnaires. These collections occur around cycles 1, 3, and 6 of your chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Changes to the gut microbiome are measured at specific points during chemotherapy (cycles 1, 3, and 6). The study also looks at recurrence-free survival and overall survival, which suggests longer-term follow-up.

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NCT07144826

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalSupportive care
Ohio State University Comprehensive Cancer Center
~161 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Biospecimen CollectionPlacebo AdministrationProbioticQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes to the gut microbiome composition
Measured over 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)

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

Explore related trials

Malignant Ovarian Neoplasm

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Laura Chambers, DO · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Changes to the gut microbiome compositionWithin 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.