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Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

NCT06109688 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-10-31

No results posted yet for this study

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.

Conditions

  • Urinary Tract Infections in Children

Interventions

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.

Sponsors & Collaborators

  • Pharmabest Sp. z o.o.

    collaborator INDUSTRY

  • Medical University of Lublin

    lead OTHER

Principal Investigators

  • Ewa Kuźma · Department of Neonate and Infant Pathology, Medical University of Lublin, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2017-12-31
Completion
2018-02-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06109688 on ClinicalTrials.gov