Actively Recruiting

Early Phase 1
Age: 18Years +
FEMALE
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

Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-02-13

161

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

Sponsors

O

Ohio State University Comprehensive Cancer Center

Lead Sponsor

D

Doris Duke Charitable Foundation

Collaborating Sponsor

AI-Summary

What this Trial 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. 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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willing to sign informed consent (with translator if needed)
  • Age over 18 years old
  • Diagnosis of advanced (stage II, III, or IV) or recurrent ovarian cancer
  • Scheduled to receive platinum-based chemotherapy as standard treatment
  • Willing to participate in all study activities
  • Agree not to take other probiotic or prebiotic supplements outside the study during participation
  • Agree not to make major diet changes during the study
  • Patients with ileostomy or colostomy allowed to participate
Not Eligible

You will not qualify if you...

  • Borderline ovarian tumors
  • Allergy or intolerance to any probiotic product
  • History of chronic inflammation or active structural problems in the digestive tract (such as inflammatory bowel disease needing medication, active ulcers, bowel obstruction, or fistula)
  • Not meeting lab requirements for platinum chemotherapy, including absolute neutrophil count below 1500
  • Known allergy to any ingredient in the study probiotic product
  • Known allergy to more than four first-line antibiotics targeting specific probiotic bacteria strains

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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