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Completed

NCT Number: NCT06109688

Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

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.

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Key information

Conditions

Urinary Tract Infections in Children Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

7 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bovine Lactoferrin

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. The number of days of hospitalization.

    Time frame: 1 month

    Length of stay. Comparing possible differences in groups.

  3. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Collaborators

  • Pharmabest Sp. z o.o.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 31, 2023
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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