Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment (NCT04118049) | Clinical Trial Compass
CompletedNot Applicable
Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment
United States141 participantsStarted 2019-10-30
Plain-language 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).
Who can participate
Age range18 Years – 89 Years
SexFEMALE
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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
What they're measuring
1
Change in vaginal microenvironment
Timeframe: Vaginal specimen assessment with gram stain will be assessed upon enrollment and after 3 months of treatment.