Assessment of the impact of different therapeutic approaches on the urobiome changes in children with recurrent urinary tract infection

Abstract

The aim is to investigate functional dynamics of urobiome in children with recurrent urinary tract infection (UTI) against the background of traditional and alternative therapy in comparison groups.
Patients and methods. A prospective, open, randomized, parallel to the design of independent groups, clinical trial was conducted during 2018–2019. The trial involved 21 girls aged 7 to 18 years old with recurrent course of UTI (at least 3–5 episodes in the last year) in the active phase of the disease. The trial participants were divided into 3 groups (7 patients each): in the 1st group, a combination of antibiotic (cephalosporin III generation) and official multivalent urological vaccine were used as basic empirical therapy; in the 2nd group — antibacterial agent (the same cephalosporin III generation as in the 1st group); in the 3rd group (patients without fever) — only urological vaccine.
The research methods include general clinical, laboratory, physical, instrumental, analytical and statistical. Statistical processing of the obtained data was performed using the STATISTICA 13 program (StatSoftInc) and MSExcel. In addition to evaluating the standard options of descriptive statistics — estimating median, mean square deviation (Ме±SD), we also solved other statistical problems for nonparametric variables: assessment of the probability of an event using the odds ratio (OR) method with a 95% confidence interval (CI), the strength of the correlation between the parameters according to the Pearson correlation criterion χ2. For all types of analysis, the differences were considered statistically significant at p <0.05 according to the Wilcoxon t-test.
Results. The efficacy of vaccine therapy without antibacterial therapy in patients with recurrent UTI who have no signs of a systemic inflammatory response has been established. The possibility of restoring the antibacterial sensitivity of resistant pathogen strains in case of multicomponent urological vaccine use in cycles of 6 months or more has been found. Standard vaccination with Urivac: 3 cycles for 3 months in a regimen of alternating 10-day use with a 20-day break. In case of medical necessity and restoration of the antibacterial sensitivity of pathogens, the course of therapy can be extended up to 6–12 months.
Conclusions. It has been shown that further applied research of alternative vaccine treatment agent will allow individualizing and reducing antibiotics use for patients with UTIs, as well as establishing mechanisms of restoring antibacterial sensitivity of microorganisms.
The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee participating institutions. The informed consent of the patient was obtained for conducting the studies.
No conflict of interest were declared by the authors.