ClinicalTrials.gg
CompletedNCT05055856Updated Mar 28, 2025

Asymptomatic Bacteriuria, Hyponatremia and Geri-atric Syndrome

An interventional study of urine sample and Blood and urine sample in Asymptomatic Bacteriuria, Frailty and Geriatric Syndrome, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Diagnostic

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Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
70 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 24 studies in Frailty with a site in Belgium — 8 open to participants now, 9 under way, none of them phase 3. Frailty · Belgium.

Enrollment
13th of 16
36 · median 110
Started
2021
with 1 other
No phase
16 of 24
5 open now
Registered
16th of 24
by date
Lead sponsor
2 of 24
Universitair Ziekenhuis Brussel

Among the 24 studies in Frailty with a site in Belgium, this one is the 13th largest by enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2021, is one of 16 with no phase, and was the 16th registered.

Frailty

1,284 studies on the registry are indexed under Frailty; 451 are open to participants now.

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Open to participants now

8 of the 24 studies in Frailty with a site in Belgium are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →

Who these studies take

Of the 299 Frailty studies recruiting now, 235 (79%) set no upper age limit and 9 (3%) stop at 75 or younger; 7 take children under 18; 66 take healthy volunteers.

This study: 70 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Frailty with a site in Belgium, or all of them as a file.
02

Study summary

The population is aging. Aged people are more prown to develop frailty. The causes of frailty are multifactorial and are being investigated in research settings. Cardiovascular diseases, inflammaging and changes in microbiota have been associated with frailty and geriatric syndrome. The prevalence of asymptomatic bacteriuria and SIADH-related hyponatremia is also important in aging and associated with inflammaging. The aim of this study is to examine, if asymptomatic bacteriuria and SIADH-related hyponatremia could be markers for frailty and geriatric syndrome.

Read the detailed description

The demographic evolution represents a challenge for the general public health. The global population, especially in the developed countries, is aging. Aging is associated with a decrease of physio-logical functions leading to frailty. Frailty is an important concept in geriatric medicine: it is a biological syndrome of decreased reserve and resistance to stressors resulting from cumulative decline across multiple physiological systems (like osteopenia, sarcopenia, dysregulation of hypothalamic axis ...). Factors that lead to frailty influence each other and can be self-perpetuating. Frailty is a geriatric syndrome but there are a lot of other geriatric syndrome such as falls, undernutrition,... When young people are sick, they present mostly more than one symptom who can be referred to one disease or one cause. In contrast, geriatric patients will present one symptom, such as confusion, fall, undernutrition,... which can be referred to multifactorial causes or diseases. This is the concept of geriatric syndrome.

Frailty or geriatric syndrome has been related to inflammaging. Inflammaging, characterized by an increase of circulating cytokines such as interleukin (IL)-6 and acute phase proteins, is a feature of immunosenescence. This process of immunosenescence is suggested to participate in the pathogene-ses of frailty and geriatric syndromes. The possible origins of inflammaging are multifactorial and controversies still exist: cardiovascular (CV) diseases, depression and chronic cytomegalovirus (CMV) infections are associated with this pro-inflammatory state. These comorbidities are highly prevalent in geriatric patients and could therefore contribute to the association between low-grade inflammation, frailty and geriatric syndromes.

The intestinal barrier and microbiota are associated with frailty and inflammaging. Multiple potential pathways exist through which the gut microbiota can provoke inflammaging (through TLR, stimulation of immune cells, translocation, endotoxines et cetera). In the same way of thinking, asymptomatic bacteriuria could also be responsible of inflammaging and frailty. The prevalence of asymptomatic bacteriuria is increased with aging and in patient with diabetes. It has also been shown to be associated with chronic inflammation (sTNFR and TNFα), increased WBCC and neutrophils. To our knowledge, it is unknown if asymptomatic bacteriuria is associated with frailty.

Hyponatremia is highly prevalent in hospitalized patients. SIADH-related hyponatremia represents 1/3 of the causes of hyponatremia. The incidence of SIADH related hyponatremia is believed to be higher in older people. It is associated with an increased risk of falls, confusion and mortality. The physiological balance between water and salt changes with aging. SIADH is classified as an euvo-lemic status; however, it is caused by an excess of water. The inappropriate secretion of vasopressin( ADH=anti-diuretic hormone) increases the expression of the aquaporins in the renal tubules. These aquaporines increase the reabsorption of water resulting in an altered ratio of reabsorption of water and Salt, leading to hyponatremia. SIADH-related hyponatremia is also associated with inflammation. IL-6 and IL-1β are able to stimulate the pituitary-hypothalamic axis to secrete vasopressin. SIADH related hyponatremia could be also a sign of inflammaging and related with frailty.

03

Conditions studied

  • Asymptomatic Bacteriuria
  • Frailty
  • Geriatric Syndrome
  • SIADH
04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥ 70 years old
  • Presence of the geriatric syndrome (dementia, depression, frailty, dependence, fall, undernu-trition, incontinence...) or not in function of the group

Exclusion criteria

Exclusion Criteria:

  • Symptoms of urinary tract infection
  • Confusion
  • CRP > 5 mg/L
  • Previous urological history
  • Intake of antibiotics
  • Intake of diuretics
  • Intake of SSRI
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Frailty or more

    patients with the geriatric syndrome who will be recruited at the geriatric out patient clinic

    Diagnostic Test: urine sample · Diagnostic Test: Blood and urine sample

  • Placebo comparator
    healthy

    healthy aged people defined as in the modified SENIEUR protocol who will be recruited by an extern call thanks UZ Brussel website of thanks to staff's knowledge

    Diagnostic Test: urine sample · Diagnostic Test: Blood and urine sample

Interventions

  • Diagnostic testurine sample

    Each participant will give a urine sample for diagnose of asymptomatic bacteriuria

  • Diagnostic testBlood and urine sample

    Each participant will give a urine and blood sample for diagnose of SIADH

06

What researchers measure

Primary outcomes

  1. asymptomatic bacteriuria

    If the presence of an asymptomatic bacteriuria is associated with frailty or the geriatric syn-drome

    Time frame: At baseline

  2. SIADH

    If the presence of SIADH-related hyponatremia is associated with frailty or geriatric syn-drome

    Time frame: At baseline

  3. SIADH and inflammaging

    If the presence of SIADH-related hyponatremia is associated with a low grade chronic in-flammation as demonstrated by a raised c-reactive protein (CRP).

    Time frame: At baseline

07

Study locations

1 site
  • UZ Brussel
    Jette, Brussel 1090, Belgium
08

References and documents

Publications

  • Fulop T, Witkowski JM, Olivieri F, Larbi A. The integration of inflammaging in age-related diseases. Semin Immunol. 2018 Dec;40:17-35. doi: 10.1016/j.smim.2018.09.003. Epub 2018 Oct 2. PubMed 30287177 ↗
  • Prio TK, Bruunsgaard H, Roge B, Pedersen BK. Asymptomatic bacteriuria in elderly humans is associated with increased levels of circulating TNF receptors and elevated numbers of neutrophils. Exp Gerontol. 2002 May;37(5):693-9. doi: 10.1016/s0531-5565(02)00002-5. PubMed 11909686 ↗
  • Swart RM, Hoorn EJ, Betjes MG, Zietse R. Hyponatremia and inflammation: the emerging role of interleukin-6 in osmoregulation. Nephron Physiol. 2011;118(2):45-51. doi: 10.1159/000322238. Epub 2010 Dec 22. PubMed 21196778 ↗
  • Bergsten G, Wullt B, Svanborg C. Escherichia coli, fimbriae, bacterial persistence and host response induction in the human urinary tract. Int J Med Microbiol. 2005 Oct;295(6-7):487-502. doi: 10.1016/j.ijmm.2005.07.008. PubMed 16238023 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Nov 2024, 37 months.

Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 37 months is above that.

Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2021
First posted
Sep 24, 2021
StartActual
Oct 30, 2021
Primary completionActual
Nov 30, 2024
CompletionActual
Nov 30, 2024
Last update
Mar 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05055856
Responsible party
Sponsor
First posted
Sep 24, 2021
Start date
Oct 30, 2021
Primary completion
Nov 30, 2024
Completion
Nov 30, 2024
Last update
Mar 28, 2025

Study contacts

Nathalie Compte, PhD
principal investigator · Universitair Ziekenhuis Brussel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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