Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

Medical University of Lublin

Status and phase: Completed; Phase 3

Conditions: Urinary Tract Infections in Children

Treatments: Dietary Supplement: Bovine Lactoferrin; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06109688

0254/297/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 7 days to 12 months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

Bovine lactoferrin

Experimental group

Description:

Sachets with bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks.

Treatment:

Dietary Supplement: Bovine Lactoferrin

Placebo

Placebo Comparator group

Description:

Matched sachets with maltodextrin for a period of 4 weeks.

Treatment:

Dietary Supplement: placebo