Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children

Prevention of Urinary Tract Infections in Children Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03462160
• Other study ID #: UTI probiotic
• Status: Not yet recruiting
• Phase: N/A
• First received: February 28, 2018
• Last updated: March 9, 2018
• Start date: April 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: February 2018
• Source: Medical University of Warsaw
• Contact: Maria Daniel, MD
• Phone: 696477117
• Email: maria.daniel[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: September 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Prevention of Urinary Tract Infections in Children
• Urinary Tract Infections

Intervention

Other:
• Placebo control group
Placebo will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal. The placebo appearance will be similar to the probiotic.

Dietary Supplement:
• Probiotic experimental group
Probiotic UroLact containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal.

Locations

Country	Name	City	State
Poland	Children's Hospital for The Medical University of Warsaw	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Miralex Sp. z o.o.

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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.201 — View Citation

Schwenger EM, Tejani AM, Loewen PS. Probiotics for preventing urinary tract infections in adults and children. Cochrane Database Syst Rev. 2015 Dec 23;(12):CD008772. doi: 10.1002/14651858.CD008772.pub2. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequencies of recurrence of UTI	New onset of symptomatic UTI within the 6 months follow-up period.	6 months after intervention
Secondary	frequencies of hospitalization due to UTI		6 months after intervention
Secondary	the number of days of antibiotic therapy due to UTI		6 months after intervention