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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04118049
Other study ID # R-HHC-2019-0069
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2019
Est. completion date May 30, 2021

Study information

Verified date March 2022
Source Hartford Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 141
Est. completion date May 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 89 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Hartford Hospital Hartford Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Hartford Hospital University of Connecticut, University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.
Secondary Pelvic Floor Disability Index (PFDI-20) The PFDI-20 will be used in order to evaluate pelvic floor symptoms. Participants will complete the PFDI-20 upon enrollment and after 3 months of treatment.
Secondary 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. Participants will complete after 1 month of use as well as at 3 months.
Secondary Urinary tract infection incidence Occurrences of urinary tract infections during the study period will be monitored. During participant involvement in the study 3-4 months.
Secondary BVAB-1 Evaluate the incidence of BVAB-1 and impact of vaginal probiotics on BVAB-1 in postmenopausal women via gram stain. Vaginal specimen will collect from participants upon enrollment and after 3 months.
Secondary 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. Vaginal specimens will be collected for cytokine analysis at enrollment and after 3 months
Secondary Incidence of adverse events (safety and tolerability) number of adverse events (vaginal irritation) from enrollment to 3 month follow up visit
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