Clinical trial NCT03462160: Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children
Official title: Effectiveness of Prophylaxis of Urinary Tract Infections in Children With a Probiotic Containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1, a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prevention of Urinary Tract Infections in Children
Keywords: Urinary Tract Infection
prophylaxis
probiotics
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Miralex Sp. z o.o.
First posted: 2018-03-12
Enrollment: 106
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aim to assess the effectiveness of prophylaxis of urinary tract infections in children with a probiotic containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1. It is formulated a hypothesis that a 3-months course of probiotic prophylasis is more effective than placebo.

Detailed description: In previously published European and global guidelines, there has been no consensus among experts regarding the prophylaxis of recurrence urinary tract infections. Depending on the recommendation, the prevention of recurrence UTI should be used, not justified, or should be used in special cases. However, preparations that will be effective in preventing UTI and will not cause bacterial resistance are still sought.

106 patients aged 3 to 18 years with recurrence UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) or children with ≥1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-days prophylaxsis arm (probiotic UroLact containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1) or a 90-days placebo arms.

The primary outcome measure will be frequencies of recurrence of UTI during the 6 months after the intervention.

Eligibility criteria: Inclusion Criteria:

* recurrent UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) OR 1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors: congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls
* ≥1 episode of urinary tract infection in the last 6 months

Exclusion Criteria:

* intake of probiotic preparations for ≥1 month in the last 3 months
* known allergy to the study products
* immunosuppression therapy
* disease with immune deficiency
* children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis

Primary outcomes:
measure: frequencies of recurrence of UTI
timeFrame: 6 months after intervention
Secondary outcomes:
measure: frequencies of hospitalization due to UTI
timeFrame: 6 months after intervention
measure: the number of days of antibiotic therapy due to UTI
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Children's Hospital for The Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Malgorzata Panczyk-Tomaszewska, Assistant Professor
role: STUDY_CHAIR
affiliation: Medical University of Warsaw
name: Maria Daniel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Warsaw
name: Hanna Szymanik-Grzelak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tewary K, Narchi H. Recurrent urinary tract infections in children: Preventive interventions other than prophylactic antibiotics. World J Methodol. 2015 Jun 26;5(2):13-9. doi: 10.5662/wjm.v5.i2.13. eCollection 2015 Jun 26.
citation: Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;2015(12):CD008772. doi: 10.1002/14651858.CD008772.pub2.
citation: Hosseini M, Yousefifard M, Ataei N, Oraii A, Mirzay Razaz J, Izadi A. The efficacy of probiotics in prevention of urinary tract infection in children: A systematic review and meta-analysis. J Pediatr Urol. 2017 Dec;13(6):581-591. doi: 10.1016/j.jpurol.2017.08.018. Epub 2017 Oct 9.
citation: Daniel M, Szymanik-Grzelak H, Turczyn A, Panczyk-Tomaszewska M. Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 versus placebo as a prophylaxis for recurrence urinary tract infections in children: a study protocol for a randomised controlled trial. BMC Urol. 2020 Oct 23;20(1):168. doi: 10.1186/s12894-020-00723-1.