Dynamics of the Urinary Bacterial Microbiota

NCT07020676 | Completed

• 2 other identifiers: 2022/0309/OBN° IDRCB : 2023-A00661-44
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Urinary Infection

Keywords

metabolomic analysis

Outcome Measures

Primary Outcomes (2)

• 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

  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"

  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).

  At enrollment visit

• Comparison of the diversity and richness of the urinary microbiota of patients in the "UI" vs "no UI" groups

  At enrollment visit

• Comparison of urinary metabolite concentrations in the "UI" vs. "no UI" groups

  At enrollment visit

Study Arms (2)

"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) "

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The target population is women, aged 18 to 45, pre-menopausal and without urinary tract abnormalities.

You may qualify if:

• Patients with UTI:
• Women
• Between 18 and 45 years old
• Premenopausal
• With biological and clinical criteria for UTI
• Without urinary tract abnormalities
• 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

You may not qualify if:

• Patients with UTI and Healthy volunteers
• Pregnancy
• Person deprived of liberty by an administrative or judicial decision, person placed under judicial protection, guardianship, or curatorship

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Service de Microbiologie - Laboratoire de Bactériologie

Rouen, 76031, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Sandrine SD DAHYOT, Doctor

  University Rouen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: November 9, 2023
• Primary Completion: March 7, 2025
• Study Completion: April 10, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

FR (1)