Ignite Creation Date:
2025-12-18 @ 8:55 AM
Ignite Modification Date:
2025-12-23 @ 9:58 PM
Study NCT ID:
NCT07020676
Status:
None
Last Update Posted:
2025-10-01 00:00:00
First Post:
2025-06-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dynamics of the Urinary Bacterial Microbiota
Sponsor:
None
Organization:
Study Overview
Official Title:
Dynamics of the Urinary Bacterial Microbiota of Patients With Urinary Tract Infection
Status:
None
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAIQUIRI
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: