Recurrent UTIsPhase 1GUD-FLORANCT07234227
Genitourinary Study of Fostering Lactobacillus to Optimize the Microbiome in Women's Health (GUD-FLORA)
A Phase 1 study testing Lactobacillus crispatus probiotic in people with Recurrent UTIs, run by Duke University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent UTIs
- What is being tested?
- Lactobacillus crispatus probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Feb 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Recurrent UTIs
- Being tested
- Lactobacillus crispatus probiotic
- Keywords
- Recurrent UTI, Microbiome, Probiotic, Vaginal probiotic, Lactobacillus, Urinary tract infection
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus crispatus probioticDrug
Also called Probiotic, VS-01(TM)
Probiotic arm (all patients)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | All patients will receive vaginal probiotic product Receives: Drug: Lactobacillus crispatus probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance
The primary endpoint is relative abundance of vaginal L. crispatus after several months of vaginally inserted L. crispatus probiotics.
Measured: 10 weeks
Secondary outcomes (2)
Number of participants with Vaginal - Urinary Correlation
Correlations in vaginal and urinary L. crispatus, at baseline and several timepoints after initiation and cessation of probiotic.
Measured: Baseline, 4, 10, and 16 weeks
Tolerability of a vaginal probiotic regimen as measured by the Vulvovaginal Symptoms Questionnaire (VSQ)
A higher score on the VSQ (range of 0 to 21) indicates lower tolerability.
Measured: Baseline, 4, 10, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study startDec 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: Study design changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent UTIsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazema Siddiqui, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234227
- Sponsor's protocol ID
- Pro00118524
- Acronym
- GUD-FLORA
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genitourinary Study of Fostering Lactobacillus to Optimize the Microbiome in Women's Health (GUD-FLORA)
- ClinicalTrials.gov ID
- NCT07234227
- Acronym / sponsor ID
- GUD-FLORA / Pro00118524
- Conditions
- Recurrent UTIs
- Keywords
- Recurrent UTI, Microbiome, Probiotic, Vaginal probiotic, Lactobacillus, Urinary tract infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Drug: Lactobacillus crispatus probioticAll patients will receive vaginal probiotic product |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus crispatus probioticAlso: Probiotic, VS-01(TM)Probiotic arm (all patients) | Drug | Probiotic Group |
Primary outcome
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.
2 secondary outcomes
Number of participants with Vaginal - Urinary Correlation
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for Recurrent UTIs
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Active, not recruiting
Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
RecruitingPhase 3
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Recurrent Urinary Tract Infections in Women
Active, not recruiting
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
Recurrent Urinary Tract Infection
RecruitingPhase 4
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazema Siddiqui, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactobacillus crispatus probiotic in people with Recurrent UTIs, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.