Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children

Medical University of Warsaw

Status: Unknown

Conditions: Prevention of Urinary Tract Infections in Children

Treatments: Dietary Supplement: Probiotic experimental group; Other: Placebo control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03462160

UTI probiotic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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106 participants in 2 patient groups, including a placebo group

Placebo supply for 90 days

Placebo Comparator group

Description:

Patients will receive placebo (in blinded sachets)

Treatment:

Other: Placebo control group

Probiotic supply for 90 days

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic experimental group