Urinary InfectionDAIQUIRINCT07020676
Dynamics of the Urinary Bacterial Microbiota
An observational study of Urinary Infection, run by University Hospital, Rouen at 1 site in France.
Trial summary
Urinary tract infections (UTIs) are one of the most common bacterial infections in humans (Flores-Mireles et al., 2015). They rank first among healthcare-associated infections (Daniau et al., 2020) and second among community-acquired infections. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Infection
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2023to 10 Apr 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The target population is women, aged 18 to 45, pre-menopausal and without urinary tract abnormalities.
Who may be able to join
- Patients with UTI:
- Women
- Between 18 and 45 years old
- Premenopausal
- With biological and clinical criteria for UTI
- Without urinary tract abnormalities
Show all 15Show fewer
- Having read the information sheet and not objecting to participation
- Patient affiliated with social security
- Healthy volunteers:
- Women
- Between 18 and 45 years old
- Premenopausal
- Without biological or clinical criteria for UTI
- Without urinary tract abnormalities
- Having read the information sheet and not objecting to participation
Who cannot join
- Patients with UTI and Healthy volunteers
- Pregnancy
- Patients who do not meet the inclusion criteria
- Person deprived of liberty by an administrative or judicial decision, person placed under judicial protection, guardianship, or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Microbiologie - Laboratoire de Bactériologie
Rouen, 76031
About this study
Official title: Dynamics of the Urinary Bacterial Microbiota of Patients With Urinary Tract Infection
Urinary tract infections (UTIs) are one of the most common bacterial infections in humans (Flores-Mireles et al., 2015). They rank first among healthcare-associated infections (Daniau et al., 2020) and second among community-acquired infections. Their diagnosis is based on the presence of urinary symptoms, confirmed by performing a urine culture culture (UCEC), which consists of collecting the patient's bladder urine. Urine samples are generally considered sterile when they do not allow the identification of uropathogenic bacteria using standard clinical culture procedures (Caron et al., 2018). However, conventional urine culture has low sensitivity, with the rate of positive urine cultures in patients with acute cystitis being estimated at 60% (Schmiemann et al., 2010). It is now established that urine has its own microbiota, that is, a set of microorganisms residing in the bladder, most of which are not cultivable under conventional laboratory conditions.
The relationship between the dynamics of urinary microbiota composition and the pathobiology of UTIs is beginning to be studied in humans (Neugent et al., 2020). Price et al. analyzed the urine of women with UTI symptoms using EQUC culture, compared to a symptom-free control group (Price et al., 2016). More precise identification of cultured bacteria revealed the presence of bacteria that were not detected using conventional culture (such as Lactobacillus iners, Gardnerella vaginalis, Prevotella sp., and Aerococcus urinae). In addition, sequencing allowed the characterization of polymicrobial communities, present in many of the samples analyzed.
These findings have led to a significant revision of the traditional perception of UTIs. It has thus been suggested that, following a disruption in the homeostasis of the urinary microbiota (urinary dysbiosis), certain bacteria considered commensals of the urinary tract can become pathogenic and lead to UTIs (Gerges-Knafl et al., 2020).
Read the detailed description
Metabolomics allows the study of an individual's metabolic profile. It provides valuable insights into the complex interplay between biology, environment, and lifestyle. Metabolites present in urine could provide unique insights into the pathogenesis of infections, including the host's immune response and the metabolic pathways of the infecting pathogen.
Furthermore, integrating urinary metabolomics with other "omics" technologies, such as microbiome, offers a more comprehensive view of the complex interactions that occur during an infection.
Existing studies of the urinary microbiome are primarily retrospective, conducted on small patient populations, and with little medical data collected.
This study therefore proposes to prospectively enroll 150 subjects (50 patients with proven UTI and 100 healthy volunteers) to study their bacterial urinary microbiota using EQUC and NGS techniques, compared to standard culture results. In addition, precise medical metadata will be collected prospectively and compared with microbiota data.
The research hypothesis is that the composition of the bacterial urinary microbiota differs between patients with clinically proven UTI and those without UTI.
This study will also test other secondary hypotheses, including:
- That certain bacterial species present in the urine of adult women are not routinely detected using standard culture conditions.
- That certain bacterial species in the urinary microbiota are not cultivable and are detectable only by NGS.
- That patients with clinically proven UTI have a lower diversity and less richness of the bacterial urinary microbiota compared to patients without UTI.
- That host factors are associated with microbial signatures.
- That the urinary metabolome of patients with UTI is different from that of healthy volunteers
- Conditions
- Urinary Infection
- Keywords
- metabolomic analysis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| "with urinary tract infection (UTI)" groups | composition of the urinary microbiota (urotypes) of patients in the "with urinary tract infection (UTI)" groups | |
| "healthy volunteer (absence of UI)" groups | composition of the urinary microbiota (urotypes) of healthy volunteers (absence of UI) " |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the urinary microbiota (urotypes) of patients in the "UI" groups
Evaluation of the abundance of different urotypes detected by the Next Generation Sequencing (NGS) technique in patients in the "UI" groups
Measured: At enrollment visit
Composition of the urinary microbiota (urotypes) of healthy volunteers "absence of UI"
Evaluation of the abundance of different urotypes detected by the Next Generation Sequencing (NGS) technique in healthy volunteers "absence of UI"
Measured: At enrollment visit
Secondary outcomes (3)
Compare the sensitivity of detecting bacteria in urine using NGS techniques (Illumina and Nanopore) compared to standard and extended culture methods (EQUC).
Evaluation of the proportion of bacterial species not detected by routine procedures but identified by EQUC and/or NGS.
Measured: At enrollment visit
Comparison of the diversity and richness of the urinary microbiota of patients in the "UI" vs "no UI" groups
Evaluation of alpha and beta diversity of urinary microbiota in patients in the "UI" vs. "no UI" groups
Measured: At enrollment visit
Comparison of urinary metabolite concentrations in the "UI" vs. "no UI" groups
Evaluation of urinary metabolite concentrations in patients in the "UI" and "no UI" groups.
Measured: At enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start9 Nov 2023
- Primary completion7 Mar 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine SD DAHYOT, Doctor, Principal investigator, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020676
- Sponsor's protocol ID
- 2022/0309/OB
- Other IDs
- N° IDRCB : 2023-A00661-44
- Acronym
- DAIQUIRI
- Status last verified
- Jan 2025
- First submitted
- 5 Jun 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of the Urinary Bacterial Microbiota of Patients With Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT07020676
- Acronym / sponsor ID
- DAIQUIRI / 2022/0309/OB
- Conditions
- Urinary Infection
- Keywords
- metabolomic analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 13 Jun 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.
Urinary tract infections (UTIs) are one of the most common bacterial infections in humans (Flores-Mireles et al., 2015). They rank first among healthcare-associated infections (Daniau et al., 2020) and second among community-acquired infections. Their diagnosis is based on the presence of urinary symptoms, confirmed by performing a urine culture culture (UCEC), which consists of collecting the patient's bladder urine. Urine samples are generally considered sterile when they do not allow the identification of uropathogenic bacteria using standard clinical culture procedures (Caron et al., 2018). However, conventional urine culture has low sensitivity, with the rate of positive urine cultures in patients with acute cystitis being estimated at 60% (Schmiemann et al., 2010). It is now established that urine has its own microbiota, that is, a set of microorganisms residing in the bladder, most of which are not cultivable under conventional laboratory conditions.
The relationship between the dynamics of urinary microbiota composition and the pathobiology of UTIs is beginning to be studied in humans (Neugent et al., 2020). Price et al. analyzed the urine of women with UTI symptoms using EQUC culture, compared to a symptom-free control group (Price et al., 2016). More precise identification of cultured bacteria revealed the presence of bacteria that were not detected using conventional culture (such as Lactobacillus iners, Gardnerella vaginalis, Prevotella sp., and Aerococcus urinae). In addition, sequencing allowed the characterization of polymicrobial communities, present in many of the samples analyzed.
These findings have led to a significant revision of the traditional perception of UTIs. It has thus been suggested that, following a disruption in the homeostasis of the urinary microbiota (urinary dysbiosis), certain bacteria considered commensals of the urinary tract can become pathogenic and lead to UTIs (Gerges-Knafl et al., 2020).
Detailed description
Metabolomics allows the study of an individual's metabolic profile. It provides valuable insights into the complex interplay between biology, environment, and lifestyle. Metabolites present in urine could provide unique insights into the pathogenesis of infections, including the host's immune response and the metabolic pathways of the infecting pathogen.
Furthermore, integrating urinary metabolomics with other "omics" technologies, such as microbiome, offers a more comprehensive view of the complex interactions that occur during an infection.
Existing studies of the urinary microbiome are primarily retrospective, conducted on small patient populations, and with little medical data collected.
This study therefore proposes to prospectively enroll 150 subjects (50 patients with proven UTI and 100 healthy volunteers) to study their bacterial urinary microbiota using EQUC and NGS techniques, compared to standard culture results. In addition, precise medical metadata will be collected prospectively and compared with microbiota data.
The research hypothesis is that the composition of the bacterial urinary microbiota differs between patients with clinically proven UTI and those without UTI.
This study will also test other secondary hypotheses, including:
- That certain bacterial species present in the urine of adult women are not routinely detected using standard culture conditions.
- That certain bacterial species in the urinary microbiota are not cultivable and are detectable only by NGS.
- That patients with clinically proven UTI have a lower diversity and less richness of the bacterial urinary microbiota compared to patients without UTI.
- That host factors are associated with microbial signatures.
- That the urinary metabolome of patients with UTI is different from that of healthy volunteers
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "with urinary tract infection (UTI)" groups | – | –composition of the urinary microbiota (urotypes) of patients in the "with urinary tract infection (UTI)" groups |
| "healthy volunteer (absence of UI)" groups | – | –composition of the urinary microbiota (urotypes) of healthy volunteers (absence of UI) " |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The target population is women, aged 18 to 45, pre-menopausal and without urinary tract abnormalities.
Key inclusion criteria (15 listed)
- Women
- Between 18 and 45 years old
- Premenopausal
- With biological and clinical criteria for UTI
- Without urinary tract abnormalities
Key exclusion criteria (4 listed)
- Patients with UTI and Healthy volunteers
- Pregnancy
- Patients who do not meet the inclusion criteria
- Person deprived of liberty by an administrative or judicial decision, person placed under judicial protection, guardianship, or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composition of the urinary microbiota (urotypes) of patients in the "UI" groups
Time frame: At enrollment visit
Evaluation of the abundance of different urotypes detected by the Next Generation Sequencing (NGS) technique in patients in the "UI" groups
Composition of the urinary microbiota (urotypes) of healthy volunteers "absence of UI"
Time frame: At enrollment visit
Evaluation of the abundance of different urotypes detected by the Next Generation Sequencing (NGS) technique in healthy volunteers "absence of UI"
3 secondary outcomes
Compare the sensitivity of detecting bacteria in urine using NGS techniques (Illumina and Nanopore) compared to standard and extended culture methods (EQUC).
Time frame: At enrollment visit
Comparison of the diversity and richness of the urinary microbiota of patients in the "UI" vs "no UI" groups
Time frame: At enrollment visit
Comparison of urinary metabolite concentrations in the "UI" vs. "no UI" groups
Time frame: At enrollment visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Yes. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
Sandrine SD DAHYOT, Doctor principal investigator
University Rouen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Infection, run by University Hospital, Rouen at 1 site in France.
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 15 inclusion and 4 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: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composition of the urinary microbiota (urotypes) of patients in the "UI" groups (time frame: At enrollment visit). The study lists 2 primary outcomes in all. 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 1 Oct 2025.