Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

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

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2021-05-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Pelvic Organ Prolapse Inflammatory Response Dysbiosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to the treatment arm versus standard care arm.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Investigators performing vaginal specimens are blinded to treatment arm.

Study Groups

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Vaginal Probiotic Arm

BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) is offered over the counter. It contains a total of 5 billion lactobacilli: L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus.

RestoreTM gel: moisturizing personal lubricant.

We will recommend to participants to use the probiotic supplement and vaginal lubricant as a vaginal suppository three times weekly at night for 3 months.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Standard Care Arm

Women will perform standard care which includes follow up at 3 months for pessary removal/care.

Group Type OTHER

Standard Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Standard Care

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal (no menstruation \>12 months)
* Subjects presenting for 2 week post initial pessary insertion appointment or presenting for routine pessary care follow up appointment
* Planning on continuing to use a pessary for treatment for at least 3 months
* Pessary maintenance performed by provider (as opposed to self-care)
* Able to understand English
* Able/willing to sign informed consent document

Exclusion Criteria

* Lack of cognitive ability to consent to participate in study and to complete the questionnaires
* Planned prolapse surgery less than 3 months from enrollment
* Presence of vaginal fistulas
* Pessary self-care (patient changes and cleans her own pessary)
* Receiving immunosuppressive therapy or history of immunodeficiency
* Presence of an indwelling vascular access line or structural heart disease
* Within 6 weeks from any abdominal or pelvic surgery or other major surgery
* Allergy to lactobacillus (contents of probiotic)
* Allergy to beta-lactam antibiotics, erythromycin and clindamycin
* Use of any probiotic pills, creams, or suppositories currently

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No