Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

Sponsor

Hartford Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04118049

Collaborator

University of Maryland (Other), University of Connecticut (Other)

141

Enrollment

Location

Arms

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Inflammatory Response Dysbiosis	Other: BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel. Other: Standard Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

141 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

Investigators performing vaginal specimens are blinded to treatment arm.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 30, 2019

Actual Primary Completion Date :

May 30, 2021

Actual Study Completion Date :

May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 Arm Women will perform standard care which includes follow up at 3 months for pessary removal/care.	Other: Standard Care Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.

Arm

Intervention/Treatment

Experimental: 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.

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 Arm

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

Other: Standard Care

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

Outcome Measures

Primary Outcome Measures

Change in vaginal microenvironment [Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.]
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) [Participants will complete the PFDI-20 upon enrollment and after 3 months of treatment.]
The PFDI-20 will be used in order to evaluate pelvic floor symptoms.
Vaginal probiotic feasibility, compliance with, and side effects of probiotic use. [Participants will complete after 1 month of use as well as at 3 months.]
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 [During participant involvement in the study 3-4 months.]
Occurrences of urinary tract infections during the study period will be monitored.
BVAB-1 [Vaginal specimen will collect from participants upon enrollment and after 3 months.]
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) [Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months]
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) [from enrollment to 3 month follow up visit]
number of adverse events (vaginal irritation)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

Female

Accepts 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