Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

Phase 3

Completed

• Conditions: Urinary Tract Infections in Children
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Bovine Lactoferrin

• Registration Number: NCT06109688
• Lead Sponsor: Medical University of Lublin

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.

Study Timeline

• Study Start: 2015-07-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-02-15
• Study First Submitted: 2020-04-27
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Matched sachets with maltodextrin for a period of 4 weeks.
Bovine lactoferrin	Bovine Lactoferrin	Sachets with bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks.

Primary Outcome Measures

Name	Time	Method
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.
Monitoring of parameters of inflammation.	at baseline, after 5 days of treatment	C-reactive protein and procalcitonin levels in both groups. Comparing possible change.
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

Name	Time	Method
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.