Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

NCT06109688 | Completed Phase 3

• 1 other identifier: 0254/297/2014
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Tract Infections in Children

Keywords

urinary tract infections; infants; lactoferrin

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• To evaluate the efficacy of lactoferrin in the reduction of probable recurrence of Urinary Tract Infection.

  1 month

• The number of days of hospitalization.

  1 month

• Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects.

  1 month

Study Arms (2)

Bovine lactoferrin

EXPERIMENTAL

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

Dietary Supplement: Bovine Lactoferrin

Placebo

PLACEBO COMPARATOR

Matched sachets with maltodextrin for a period of 4 weeks.

Dietary Supplement: placebo

Interventions

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.

Also known as: Lactoferrin 100 mg

Bovine lactoferrin

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.

Also known as: Maltodextrin

Placebo

Eligibility Criteria

• Age: 7 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lublin: lead
• Pharmabest Sp. z o.o.: collaborator

Related Publications (7)

• Manzoni P, Dall'Agnola A, Tome D, Kaufman DA, Tavella E, Pieretto M, Messina A, De Luca D, Bellaiche M, Mosca A, Piloquet H, Simeoni U, Picaud JC, Del Vecchio A. Role of Lactoferrin in Neonates and Infants: An Update. Am J Perinatol. 2018 May;35(6):561-565. doi: 10.1055/s-0038-1639359. Epub 2018 Apr 25.

  PMID: 29694997 BACKGROUND

• Artym J, Zimecki M. [The role of lactoferrin in the proper development of newborns]. Postepy Hig Med Dosw (Online). 2005;59:421-32. Polish.

  PMID: 16106243 BACKGROUND

• Balighian E, Burke M. Urinary Tract Infections in Children. Pediatr Rev. 2018 Jan;39(1):3-12. doi: 10.1542/pir.2017-0007. No abstract available.

  PMID: 29292282 BACKGROUND

• Garout WA, Kurdi HS, Shilli AH, Kari JA. Urinary tract infection in children younger than 5 years. Etiology and associated urological anomalies. Saudi Med J. 2015 Apr;36(4):497-501. doi: 10.15537/smj.2015.4.10770.

  PMID: 25828291 BACKGROUND

• Renata Y, Jassar H, Katz R, Hochberg A, Nir RR, Klein-Kremer A. Urinary concentration of cytokines in children with acute pyelonephritis. Eur J Pediatr. 2013 Jun;172(6):769-74. doi: 10.1007/s00431-012-1914-2. Epub 2013 Feb 7.

  PMID: 23389820 BACKGROUND

• Krzemien G, Szmigielska A, Turczyn A, Panczyk-Tomaszewska M. Urine interleukin-6, interleukin-8 and transforming growth factor beta1 in infants with urinary tract infection and asymptomatic bacteriuria. Cent Eur J Immunol. 2016;41(3):260-267. doi: 10.5114/ceji.2016.63125. Epub 2016 Oct 25.

  PMID: 27833443 BACKGROUND

• Miguel-Bayarri V, Casanoves-Laparra EB, Pallas-Beneyto L, Sancho-Chinesta S, Martin-Osorio LF, Tormo-Calandin C, Bautista-Rentero D. Prognostic value of the biomarkers procalcitonin, interleukin-6 and C-reactive protein in severe sepsis. Med Intensiva. 2012 Nov;36(8):556-62. doi: 10.1016/j.medin.2012.01.014. Epub 2012 Apr 10. English, Spanish.

  PMID: 22495097 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Lactoferrin; maltodextrin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Ewa Kuźma

  Department of Neonate and Infant Pathology, Medical University of Lublin, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: October 31, 2023
• Study Start: July 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: February 15, 2018
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share