Can Probiotics be Used in the Prevention of Recurrent UTI in Paediatric Neurogenic Bladder
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Although clean intermittent catheterization (CIC) remains the mainstay to ensure complete
low-pressure bladder emptying in neurogenic bladder (NB) patients, this forms a vehicle for
bacterial entry and colonization of the urinary tract, which can lead to recurrent urinary
tract infection (RUTI) and renal damage. Up to 25% of NB patients on CIC suffer from RUTI and
daily, low-dose antibiotic prophylaxis is widely prescribed to prevent these infections.
Unfortunately, this therapeutic option is not evidence-based and can be associated with a
higher risk of RUTI secondary to development of antibiotic resistance. In addition, many
children suffer from a range of adverse reactions and emergence of drug resistant organisms.
Moreover, recent studies have shown that antibiotics cause a major disruption in the human
microbiome, potentially leading to long term major problems.
Probiotics are live microorganisms, which when administered in adequate amounts confer a
health benefit on the host. There is evidence that probiotics restore microbial homeostasis
in the vagina, reduce the risk of pathogen ascension into the bladder, and modulate immunity
to better protect the host. Probiotic strains, including Lactobacillus rhamnosus GR-1,
Lactobacillus reuteri B-54 and RC-14, have been shown to be safe and efficacious in an oral
formulation or as a vaginal suppository in improving the microbiota profile of the vagina and
decreasing the risk of RUTI. Various mechanisms appear to be involved, including modulating
antimicrobial and inflammatory defenses, up-regulating protective mucin production and
reducing the pressure on pathogens to acquire antibiotic resistance genes. A randomized trial
comparing probiotics to antibiotic prophylaxis in children with vesicoureteric reflux showed
equivalent reduction in the incidence of RUTI and development of new renal scarring. In
addition, down regulation of inflammatory cytokines can potentially favorably alter bladder
function and prevent bladder fibrosis.
Investigators at London Health Sciences Centre (LHSC) have the opportunity to acquire
clinical data that would strengthen the case for probiotics to be integrated into pediatric
urology practice for managing CIC and RUTI. This would be the first such study in pediatric
NB patients.
The main objective of this study is to determine whether the use of probiotics (lactobacilli)
can decrease the impact of adverse side effects and the antibiotic resistance that is seen
with the prolonged use of antibiotics for patients with neurogenic bladder conditions.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
London Health Sciences Centre
Collaborator:
Canadian Urological Association
Treatments:
Anti-Bacterial Agents Antibiotics, Antitubercular Sulfamethoxazole Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination