Clinical Research Directory

Genitourinary Study of Fostering Lactobacillus to Optimize the Microbiome in Women's Health (GUD-FLORA)

Sponsor: Duke University

Summary

The objective of this study is to evaluate the use of a vaginal probiotic in patients with recurrent urinary tract infections (UTIs). Specifically, this study aims to evaluate factors associated with successful colonization with Lactobacillus crispatus - a known "healthy" and protective bacteria in both the vaginal and urinary microenvironments. The study will recruit patients over age 18 with a clinical diagnosis of recurrent UTIs, and will utilize a commercially available Lactobacillus vaginal probiotic. Participants will use the probiotic product with the commercially approved packaging and regimen for a total of 3 months. Vaginal and urinary samples will be obtained at four different timepoints. Participants will also be asked to complete surveys regarding tolerability and acceptability of the probiotic product. Patient samples will be analyzed in the laboratory to understand the effects of the probiotic on the local microbiome. Survey data and demographic information will be housed within the Research Electronic Data Capture (RedCap) secure server. For our primary analysis, Lactobacillus crispatus (L. crispatus) abundance will be measured and used as the outcome variable in a linear regression model evaluating the impact of baseline patient and microbiome characteristics on L. crispatus colonization.

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Interventions