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

NCT07234227 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Pro00118524
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Recurrent UTIs

Keywords

Recurrent UTI; Microbiome; Probiotic; Vaginal probiotic; Lactobacillus; Urinary tract infection

Outcome Measures

Primary Outcomes (1)

• Relative abundance

  The primary endpoint is relative abundance of vaginal L. crispatus after several months of vaginally inserted L. crispatus probiotics.

  10 weeks

Secondary Outcomes (2)

• Number of participants with Vaginal - Urinary Correlation

  Baseline, 4, 10, and 16 weeks

• Tolerability of a vaginal probiotic regimen as measured by the Vulvovaginal Symptoms Questionnaire (VSQ)

  Baseline, 4, 10, and 16 weeks

Study Arms (1)

Probiotic Group

EXPERIMENTAL

All patients will receive vaginal probiotic product

Drug: Lactobacillus crispatus probiotic

Interventions

Lactobacillus crispatus probiotic DRUG

Probiotic arm (all patients)

Also known as: Probiotic, VS-01(TM)

Probiotic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• ≥ 18 years of age
• Diagnosed with recurrent urinary tract infections (UTIs). Specifically, participants will have had 3 UTIs over the past 12 months or 2 UTIs over the past 6 months. At least one of these UTIs must be culture-proven. For UTIs to count for this study, if not culture-proven they must involve the onset of UTI-related symptoms (dysuria, urgency, frequency, suprapubic pain, or urinary changes, etc) with prescription of antibiotics directed at UTI treatment.

You may not qualify if:

• Chronically self-catheterize.
• Currently use of a vaginal pessary.
• Have used a vaginal probiotic in the prior 3 months.
• Are pregnant or within 1 year postpartum.
• Have poorly controlled diabetes with an A1c of 9 or greater.
• Are considered immunocompromised
• Are unable to personally provide legal consent

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Nazema Siddiqui, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Howell

CONTACT

919-684-8111; elizabeth.howell@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share