Cystitis Urinary tract infection
Conditions
Interventions
None
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal woman, defined as having had the last menstrual period at least 12 months ago. 2. RUTI group: having had a UTI at least three times in the last 12 months OR Control group: not having had a UTI in the last 12 months and never having had a RUTI diagnosis in the past. 3. Willing and able to complete the expected tasks described in the study protocol, including answering questions in Dutch or English; allowing home visits by study staff as needed; allowing study staff to obtain medical information relevant to the study objectives from the GP; and allowing study staff to share pseudonymised study samples and data (i.e. identified by participant identification code only) within the UTIr project consortium.
Exclusion criteria
Exclusion criteria: 1. Having an anatomical abnormality or chronic disease of the urinary tract or kidneys, or having received a kidney transplant. 2. Having a urinary catheter in place. 3. Using exogenous progestogens and/or oestrogens and/or anti-oestrogen treatment. Women become eligible again if their last hormonal use is at least 6 months ago. 4. Having a chronic condition and/or using medications that significantly influence the immune system and/or bacterial growth. Women become eligible again if their last medication use is at least 6 months ago. Women who use supplements to prevent or treat UTIs (such as cranberries or d-mannose) are eligible. Women cannot use vaginal probiotics containing lactobacilli during the study; they can be enrolled after at least one month has passed since their last use. 5. Having to undergo a substantial planned medical intervention, such as surgery, during the follow-up period. 6. Planning a prolonged absence from the Netherlands during the follow-up period. 7. Women in both groups who have a genital infection at the time of recruitment must first be treated for that infection and can be included when at least 2 weeks have passed after the end of treatment and they are symptom-free. 8. Women in the RUTI group who have a UTI at the time of recruitment can be included but baseline procedures will be slightly adjusted. 9. Women in the RUTI group who use antibiotics chronically to manage their RUTI, or vaginal oestrogen-containing creams for RUTI prophylaxis, will be excluded in the first instance but may become eligible later on during recruitment if required to reach recruitment targets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urobiome composition by 16S rRNA sequencing/qPCR: alpha and beta diversities, relative and absolute abundances of key taxa (typically up to genus level), and urobiome clusters (urotypes). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Urobiome composition by metagenomic sequencing: same as above but at species and strains level; plus relative abundances of bacterial (other than bacterial 16S genes) and non-bacterial genes in urine. • Vaginal, vulvoperineal, and intestinal microbiome composition - same endpoints as described above for urobiome composition. • Urine metabolome composition. • Results of the co-culture and urothelium organoid experiments with bacterial isolates obtained from samples collected in the cohort study. | — |
Countries
Netherlands
Contacts
Public ContactJHHM van de Wijgert
Universitair Medisch Centrum Utrecht
Outcome results
None listed