Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

Sponsor

Medical University of Lublin (Other)

Overall Status

Completed

CT.gov ID

NCT06109688

Collaborator

Pharmabest Sp. z o.o. (Industry)

Enrollment

Arms

31.5

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections in Children	Dietary Supplement: Bovine Lactoferrin Dietary Supplement: placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

patients with Urinary Tract Infections were recruited subjects were randomized into two groups: the experimental group received bLF the control group received placebo without bLFpatients with Urinary Tract Infections were recruited subjects were randomized into two groups: the experimental group received bLF the control group received placebo without bLF

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Feb 15, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Days to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.