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

NCT07144826 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-24095NCI-2025-05052
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Changes to the gut microbiome composition

  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.

  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)

Secondary Outcomes (5)

• Patient compliance with taking probiotic pills

  At chemotherapy visits for cycle 2, 3, 4, 5, and 6 (cycle length = 21 days)

• Patient compliance with gut microbiome collection

  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)

• Patient compliance with vaginal microbiome collection

  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)

• Recurrence free survival (RFS)

  Months from first cycle of chemotherapy (cycle 1) to time of recurrence defined by primary physician assessment (cycle length = 21 days)

• Overall survival (OS)

  Months from first cycle of chemotherapy (cycle 1) to time of death (cycle length = 21 days)

Study Arms (2)

Arm I (probiotic)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Dietary Supplement: Probiotic; Other: Questionnaire Administration

Arm II (placebo)

PLACEBO COMPARATOR

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.

Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and vaginal sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (probiotic); Arm II (placebo)

Placebo Administration DRUG

Given PO

Arm II (placebo)

Probiotic DIETARY_SUPPLEMENT

Given PO

Also known as: Probiotic Supplement, Probiotic supplements (pills, liquid, powder; or other probiotics)

Arm I (probiotic)

Questionnaire Administration OTHER

Ancillary studies

Arm I (probiotic); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Doris Duke Charitable Foundation: collaborator
• Ovarian Cancer Research Alliance: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Specimen Handling; Probiotics; Fluid Therapy; Powders

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Drug Therapy; Therapeutics; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Laura Chambers, DO

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: March 9, 2026
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): July 9, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)