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Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

Primary Purpose

Pelvic Organ Prolapse, Inflammatory Response, Dysbiosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Standard Care

About this trial

This is an interventional basic science trial for Pelvic Organ Prolapse focused on measuring Pessary use, Probiotics, Cytokines, Microenvironment

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Vaginal Probiotic Arm

Standard Care Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in vaginal microenvironment

Change in vaginal microenvironment on gram stain measuring lactobacilli, anaerobic bacteria, and mobiluncus, WBCs and epithelial cell maturation reported as Nugent Subscore.

Secondary Outcome Measures

Pelvic Floor Disability Index (PFDI-20)

The PFDI-20 will be used in order to evaluate pelvic floor symptoms.

Vaginal probiotic feasibility, compliance with, and side effects of probiotic use.

Unvalidated questionnaires (vaginal products and hromonal therapy questionnaire, subjective vaginal experiences over the past month questionnaire, and a vaginal probiotic questionnaire) were created in order to evaluate participant experiences with vaginal probiotics including feasibility, impact on symptoms from pessary use, and side effects from use. These questionnaires do not have scales.

Urinary tract infection incidence

Occurrences of urinary tract infections during the study period will be monitored.

BVAB-1

Evaluate the incidence of BVAB-1 and impact of vaginal probiotics on BVAB-1 in postmenopausal women via gram stain.

Pro-inflammatory cytokines (Interleukin (IL-6)), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin(IL-1alpha) and Interleukin (IL-1beta)

Pro-inflammatory cytokines will be evaluated from vaginal specimens collected in order to evaluate (1) the impact of probiotics on the inflammatory environment of the vagina (2) longitudinal assessment of pro-inflammatory cytokines in pessary wearing patients.

Incidence of adverse events (safety and tolerability)

number of adverse events (vaginal irritation)

Full Information

NCT ID

NCT04118049

First Posted

October 1, 2019

Last Updated

March 24, 2022

Sponsor

Hartford Hospital

Collaborators

University of Maryland, University of Connecticut

1. Study Identification

Unique Protocol Identification Number

NCT04118049

Brief Title

Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

Official Title

The Effect of Vaginal Probiotics on the Vaginal Microenvironment in Patients Using Vaginal Pessaries: a Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

October 30, 2019 (Actual)

Primary Completion Date

May 30, 2021 (Actual)

Study Completion Date

May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hartford Hospital

Collaborators

University of Maryland, University of Connecticut

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse, Inflammatory Response, Dysbiosis

Keywords

Pessary use, Probiotics, Cytokines, Microenvironment

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

Investigators performing vaginal specimens are blinded to treatment arm.

Allocation

Randomized

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaginal Probiotic Arm

Arm Type

Experimental

Arm Description

Arm Title

Standard Care Arm

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

Standard Care

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in vaginal microenvironment

Description

Change in vaginal microenvironment on gram stain measuring lactobacilli, anaerobic bacteria, and mobiluncus, WBCs and epithelial cell maturation reported as Nugent Subscore.

Time Frame

Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.

Secondary Outcome Measure Information:

Title

Pelvic Floor Disability Index (PFDI-20)

Description

The PFDI-20 will be used in order to evaluate pelvic floor symptoms.

Time Frame

Participants will complete the PFDI-20 upon enrollment and after 3 months of treatment.

Title

Vaginal probiotic feasibility, compliance with, and side effects of probiotic use.

Description

Time Frame

Participants will complete after 1 month of use as well as at 3 months.

Title

Urinary tract infection incidence

Description

Occurrences of urinary tract infections during the study period will be monitored.

Time Frame

During participant involvement in the study 3-4 months.

Title

BVAB-1

Description

Evaluate the incidence of BVAB-1 and impact of vaginal probiotics on BVAB-1 in postmenopausal women via gram stain.

Time Frame

Vaginal specimen will collect from participants upon enrollment and after 3 months.

Title

Pro-inflammatory cytokines (Interleukin (IL-6)), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin(IL-1alpha) and Interleukin (IL-1beta)

Description

Time Frame

Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months

Title

Incidence of adverse events (safety and tolerability)

Description

number of adverse events (vaginal irritation)

Time Frame

from enrollment to 3 month follow up visit

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth Sappenfield, MD

Organizational Affiliation

Hartford Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hartford Hospital

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

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