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Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

NCT04118049 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2022-03-25

No results posted yet for this study

Summary

In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment (cytokines).

Conditions

  • Pelvic Organ Prolapse
  • Inflammatory Response
  • Dysbiosis

Interventions

OTHER

BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.

BiopHreshTM is a vaginal probiotic supplement that is offered over the counter and contains four different lactobacilli strains (L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus). RestoreTM is a moisturizing personal lubricant that has been on the market for three years. Participants will use 1 probiotic capsule with RestoreTM gel nightly three times weekly.

OTHER

Standard Care

Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER

  • University of Connecticut

    collaborator OTHER

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Elisabeth Sappenfield, MD · Hartford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2021-05-30
Completion
2021-05-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118049 on ClinicalTrials.gov