Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

Hartford Hospital

Status: Completed

Conditions: Dysbiosis; Inflammatory Response; Pelvic Organ Prolapse

Treatments: Other: Standard Care; Other: BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.

Study type: Interventional

Funder types: Other

Identifiers

NCT04118049

R-HHC-2019-0069

Details and patient eligibility

About

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).

Enrollment: 141 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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141 participants in 2 patient groups

Vaginal Probiotic Arm

Experimental group

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.

Treatment:

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

Standard Care Arm

Other group

Description:

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

Treatment:

Other: Standard Care