Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children

NCT03462160 | Unknown DMC

• 1 other identifier: UTI probiotic
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention of Urinary Tract Infections in Children

Keywords

Urinary Tract Infection; prophylaxis; probiotics

Outcome Measures

Primary Outcomes (1)

• frequencies of recurrence of UTI

  New onset of symptomatic UTI within the 6 months follow-up period.

  6 months after intervention

Secondary Outcomes (2)

• frequencies of hospitalization due to UTI

  6 months after intervention

• the number of days of antibiotic therapy due to UTI

  6 months after intervention

Study Arms (2)

Placebo supply for 90 days

PLACEBO COMPARATOR

Patients will receive placebo (in blinded sachets)

Other: Placebo control group

Probiotic supply for 90 days

EXPERIMENTAL

Patients will receive probiotics containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 (in blinded sachets).

Dietary Supplement: Probiotic experimental group

Interventions

Placebo control group OTHER

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.

Placebo supply for 90 days

Probiotic experimental group DIETARY_SUPPLEMENT

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.

Probiotic supply for 90 days

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Miralex Sp. z o.o.: collaborator

Study Sites (1)

Children's Hospital for The Medical University of Warsaw

Warsaw, 02-091, Poland

Location

Related Publications (4)

• 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.

  PMID: 26140267 RESULT

• 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.

  PMID: 26695595 RESULT

• 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.

  PMID: 29102297 RESULT

• 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.

  PMID: 33097017 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Malgorzata Panczyk-Tomaszewska, Assistant Professor

  Medical University of Warsaw

  STUDY CHAIR

• Maria Daniel, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Hanna Szymanik-Grzelak, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Daniel, MD

CONTACT

696477117; maria.daniel@wum.edu.pl

Hanna Szymanik-Grzelak, PhD

CONTACT

223179656; h.szymanik@interia.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 12, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 12, 2018

Record last verified: 2018-02

Locations

PL (1)