Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

October 25, 2023 updated by: Medical University of Lublin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neonates and infants with symptoms of Urinary Tract Infection.
  • Active infection at enrollment, confirmed and documented in medical record.
  • Children with Urinary Tract Infection treated according to current recommendations.

Exclusion Criteria:

  • Unconfirmed Urinary Tract Infection.
  • Critical illness and/or hemodynamic instability.
  • Allergy or sensitivity to lactoferrin or bovine derived proteins or bovine milk.
  • Children whose parents/guardians decline to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bovine lactoferrin
Sachets with bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks.
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.
Other Names:
  • Lactoferrin 100 mg
Placebo Comparator: Placebo
Matched sachets with maltodextrin for a period of 4 weeks.
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.
Other Names:
  • Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitoring of parameters of inflammation.
Time Frame: at baseline, after 5 days of treatment
C-reactive protein and procalcitonin levels in both groups. Comparing possible change.
at baseline, after 5 days of treatment
Influence of lactoferrin on Interleukin-6 and Interleukin-8.
Time Frame: at baseline, after 5 days of treatment
Levels of Interleukin in both groups. Comparing possible change.
at baseline, after 5 days of treatment
Effect of lactoferrin on white blood cells.
Time Frame: at baseline, after 5 days of treatment
To assess the change in the number of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.
at baseline, after 5 days of treatment
Effect of lactoferrin on urinary inflammatory markers.
Time Frame: at baseline, after 5 days of treatment
The presence of bacteria in urine and semi-quantitative measurement of white blood cells count in urine.
at baseline, after 5 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of lactoferrin in the reduction of probable recurrence of Urinary Tract Infection.
Time Frame: 1 month
The number of recurrent Urinary Tract Infections occur due to bacterial reinfection or bacterial persistence.
1 month
The number of days of hospitalization.
Time Frame: 1 month
Length of stay. Comparing possible differences in groups.
1 month
Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects.
Time Frame: 1 month
Incidence, frequency and severity of treatment emergent adverse events.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Collaborators

Pharmabest Sp. z o.o.

Investigators

  • Principal Investigator: Ewa Kuźma, Department of Neonate and Infant Pathology, Medical University of Lublin, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0254/297/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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