Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

Urinary Tract Infections in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06109688
• Other study ID #: 0254/297/2014
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2015
• Est. completion date: February 15, 2018

Study information

• Verified date: October 2023
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 15, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Days to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Tract Infections
• Urinary Tract Infections in Children

Intervention

Dietary Supplement:
• Bovine Lactoferrin
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.
• placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Lublin	Pharmabest Sp. z o.o.

References & Publications (7)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring of parameters of inflammation.	C-reactive protein and procalcitonin levels in both groups. Comparing possible change.	at baseline, after 5 days of treatment
Primary	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
Primary	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
Primary	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	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
Secondary	The number of days of hospitalization.	Length of stay. Comparing possible differences in groups.	1 month
Secondary	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