FindMyKOL
Clinical trialNCT07234227Not, yet, recruitingPhase 1Interventional

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

SponsorDuke UniversityEnrollment0Recurrent UTIs
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Lactobacillus crispatus probiotic
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Dec 2026
Primary completion
30 Nov 2027
Completion
29 Feb 2028
Last update posted
28 Aug 2026
Registered enrollment
0
Registry id
NCT07234227

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.