Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

Study Overview
=================
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.

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.

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

Conditions
-----------------
Urinary Tract Infections in Children

Intervention / Treatment
-----------------
* Dietary Supplement: Bovine Lactoferrin
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 7 Days
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bovine lactoferrin<br>Sachets with bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks. | Dietary Supplement: Bovine Lactoferrin<br>* 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.<br>* Other names: Lactoferrin 100 mg;|
| Placebo Comparator: Placebo<br>Matched sachets with maltodextrin for a period of 4 weeks. | Dietary Supplement: placebo<br>* 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.<br>* Other names: Maltodextrin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring of parameters of inflammation. | 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. | Levels of Interleukin in both groups. Comparing possible change. | at baseline, after 5 days of treatment | 
| Effect of lactoferrin on white blood cells. | 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. | 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. | The number of recurrent Urinary Tract Infections occur due to bacterial reinfection or bacterial persistence. | 1 month | 
| The number of days of hospitalization. | Length of stay. Comparing possible differences in groups. | 1 month | 
| Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects. | Incidence, frequency and severity of treatment emergent adverse events. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary tract infections, infants, lactoferrin