NCT06109688

Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants: a Randomised, Double-blind, Placebo-controlled Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Medical University of Lublin · Academic / Other
• Sex: All
• Age: 7 Days – 12 Months
• Healthy volunteers: Not accepted

Summary

The aim of the study was to evaluate the efficacy of orally administered bovine lactoferrin (bLF) on Urinary Tract Infections in neonates and infants. Fifty-five patients with urinary tract infection were randomized to receive either bLF (n = 27) or an identical placebo (n = 28) for 4 weeks. The patients were assessed clinically and laboratory.

Detailed description

This study was a prospective randomized controlled trial at a single university medical center. Participants were neonates or infants with Urinary Tract Infection (UTI) admitted to the Neonatal and Infant Pathology Department of Children's University Hospital in the period from July 2015 to December 2017. The intervention was bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks compared with placebo in a control group. During hospital treatment, laboratory tests were performed to evaluate the activity of inflammatory markers (C-reactive protein, procalcitonin, Interleukin-6 and Interleukin-8 levels and white blood cell count). Fifty-five patients heve been included in the study.

Conditions

• Urinary Tract Infections in Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bovine Lactoferrin	Orally intake 1 sachet per day for 4 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution.
DIETARY_SUPPLEMENT	placebo	Orally intake 1 sachet per day for 4 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-12-31
• Completion: 2018-02-15
• First posted: 2023-10-31
• Last updated: 2023-10-31