The primary objective is to explore the urine microbiome (urobiome) composition of postmenopausal women with and without RUTI at five scheduled time points during one year of follow-up, as well as before, during, and after UTI episodes when they…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
• 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.
Background summary
Recurrent urinary tract infections (RUTI) are very common in postmenopausal
women. The biological evidence-base required to improve diagnostic methods,
prevention interventions, and clinical management needs strengthening.
Study objective
The primary objective is to explore the urine microbiome (urobiome) composition
of postmenopausal women with and without RUTI at five scheduled time points
during one year of follow-up, as well as before, during, and after UTI episodes
when they occur. Secondary objectives are to compare urobiome to vaginal,
vulvoperineal, and intestinal microbiome compositions in the same women at the
same sampling time points; to explore the metagenome and metabolome in a subset
of women/samples; to make the cohort samples and data available for related
mechanistic research; and to translate the findings to improved clinical
diagnostics for the (early) detection of UTIs. The overall goal is to improve
the treatment and prevention of UTIs in postmenopausal women with a RUTI
diagnosis.
Study design
Observational prospective cohort study.
Study burden and risks
The study participants will not benefit directly from study participation other
than receiving a reimbursement for their travel and time. The risks are judged
as negligible because the study does not include any interventions. The
logistics burden is judged as potentially high, depending on a participant*s
personal circumstances and the number of UTIs during follow-up: all
participants will be asked to visit the UMCU, host home visits, and/or
self-sample at 5 scheduled time points during the year, and women who
experience UTIs will be asked to host two additional home visits, and several
additional days of self-sampling, per UTI episode. To minimise risks and
burdens, women will be trained and supported by study staff, and some
flexibility with study procedures will be allowed to ensure that burdens remain
within each woman*s personal limits.
Universiteitsweg 100
Utrecht 3584 CG
NL
Universiteitsweg 100
Utrecht 3584 CG
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84448.041.23 |