Genitourinary Study of Fostering Lactobacillus to Optimize the Microbiome in Women's Health (GUD-FLORA) (GUD-FLORA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, observational study in patients with recurrent UTIs seeking care in the Duke Division of Urogynecology.
After obtaining informed consent, baseline samples and questionnaires will be completed during an in person visit. Clinical data will be abstracted from the medical record. At the baseline visit, participants will be supplied a 3-month course of the VS-01TM vaginal probiotic, manufactured by Seed Health, Inc. VS-01TM is a commercially available dissolving tablet containing three strains of L. crispatus. The tablet is self-administered vaginally via a supplied applicator.
Participants will follow the recommended dosing regimen (e.g., Days 1, 4, 7, 14, 21, 28, then every other week) to total 3 months.
No existing patient therapies for recurrent UTIs will be discontinued or prohibited during the study period. Patients will be encouraged to continue any stable/existing medications for UTI prevention such as vaginal estrogen. No placebo control will be utilized.
Participants will be supplied with at-home sampling kits for sample collection. Final sampling occurs once month after completion of the probiotic regimen, with samples banked for future analyses to determine whether colonization persists after cessation of the probiotic. Sampling will occur at baseline and at weeks 4, 10, and 16. Each sampling time point will include a urine sample and a vaginal swab. The baseline sample will also include a pH test via pH paper strip.
Home sampling procedures will be similar to those recently published by a large consortium. Participants will return sampling kits via pre-paid, pre-addressed shippers through our laboratory account. Due to the at-home nature of patient sample collection, no additional visits to clinic will be required. Patients will have access to routine clinic visits per standard of care.
Upon receipt in the lab, samples will be processed, and DNA will be extracted. Prepared samples with positive and negative controls will be evaluated for microbial abundance. For our primary analysis, absolute abundance of L. crispatus at baseline and subsequent timepoints will be evaluated using digital droplet PCR. In addition, the investigators will plan to pursue additional funding for sequence-based analyses of L. crispatus and other species. For these additional analyses, samples would be submitted to the Duke Microbiome Core for library preparation, amplification, and sequencing of the full-length 16S rRNA gene. Taxonomic identification will be performed with standard pipelines and relative abundance of L. crispatus and other species will be quantified.
With respect to survey data, all will be completed electronically either in clinic (baseline via iPads), or at home (link sent to designated email), and stored through Research Electronic Data Capture (REDCap). The questionnaires utilized are the Vulvovaginal Symptoms Questionnaire (VSQ) and an acceptability questionnaire. These are validated questionnaires to assess patient tolerability and acceptability, respectively, of the vaginal probiotic regimen.
Study Type
Phase
- Phase 1
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Probiotic Group
All patients will receive vaginal probiotic product
|
Probiotic arm (all patients)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative abundance
Time Frame: 10 weeks
|
The primary endpoint is relative abundance of vaginal L. crispatus after several months of vaginally inserted L. crispatus probiotics.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with Vaginal - Urinary Correlation
Time Frame: Baseline, 4, 10, and 16 weeks
|
Correlations in vaginal and urinary L. crispatus, at baseline and several timepoints after initiation and cessation of probiotic.
|
Baseline, 4, 10, and 16 weeks
|
|
Tolerability of a vaginal probiotic regimen as measured by the Vulvovaginal Symptoms Questionnaire (VSQ)
Time Frame: Baseline, 4, 10, and 16 weeks
|
A higher score on the VSQ (range of 0 to 21) indicates lower tolerability.
|
Baseline, 4, 10, and 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nazema Siddiqui, MD, Duke University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00118524
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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