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

NCT ID: NCT07144826

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-09

Study Completion Date

2027-07-09

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. To evaluate changes to the gut microbiome composition in ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy.

SECONDARY OBJECTIVES:

I. Compliance with probiotic intervention in ovarian cancer patients during chemotherapy.

II. Compliance with gut microbiome collection in ovarian cancer patients during chemotherapy.

III. Compliance with vaginal microbiome collection in ovarian cancer patients during chemotherapy.

IV. Recurrence free survival (RFS). V. Overall survival (OS).

EXPLORATORY OBJECTIVES:

I. To evaluate changes in the vaginal microbiome composition of ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy.

II. Assess pre-chemotherapy diet according to the Food Frequency Questionnaire (FFQ, Diet History Questionnaire \[DHQ3\]) questionnaire and how this influences the patient's baseline gut and vaginal microbiome.

III. Assess whether a probiotic intervention influences chemotherapy toxicity and morbidity.

IV. Assess whether a probiotic intervention influences stool consistency or need for additional medications during chemotherapy.

V. Assess impact of gut and vaginal microbiome on patient quality of life. VI. Assess changes in serum metabolomic and immune markers as a result of the probiotic intervention.

VII. Assess whether probiotic intervention is associated with chemotherapy-induced neutropenia, neutropenic fever and dose-delays.

VIII. In patients who undergo standard-of-care surgery during chemotherapy, assessment of post-operative infectious outcomes, including surgical site infection in ovarian cancer patients randomized to a probiotic intervention versus placebo during platinum chemotherapy.

IX. In patients who undergo standard-of-care surgery during chemotherapy, assessment of the tumor microbiome as a result of probiotic intervention versus placebo.

X. In patients who are treated with antibiotics as standard of care for infectious causes during chemotherapy, assess changes in the vaginal and gut microbiome related to antibiotic therapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive probiotic orally (PO) twice daily (BID) beginning within seven days of standard of care (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.

ARM II: 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.

Conditions

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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 Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood and vaginal sample collection

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Given PO

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type PLACEBO_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood and vaginal sample collection

Placebo Administration

Intervention Type DRUG

Given PO

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo blood and vaginal sample collection

Intervention Type PROCEDURE

Placebo Administration

Given PO

Intervention Type DRUG

Probiotic

Given PO

Intervention Type DIETARY_SUPPLEMENT

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Probiotic Supplement Probiotic supplements (pills, liquid, powder; or other probiotics)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Laura Chambers

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Chambers, DO

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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The Ohio State University Comprehensive Cancer Center

Role: CONTACT

Phone: 800-293-5066

Email: [email protected]

Facility Contacts

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Laura Chambers, DO

Role: primary

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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NCI-2025-05052

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-24095

Identifier Type: -

Identifier Source: org_study_id