Clinical trial NCT06109688: Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.
Official title: Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants: a Randomised, Double-blind, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Infections in Children
Keywords: urinary tract infections
infants
lactoferrin
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: Pharmabest Sp. z o.o.
First posted: 2023-10-31
Enrollment: 55
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Monitoring of parameters of inflammation.
timeFrame: at baseline, after 5 days of treatment
measure: Influence of lactoferrin on Interleukin-6 and Interleukin-8.
timeFrame: at baseline, after 5 days of treatment
measure: Effect of lactoferrin on white blood cells.
timeFrame: at baseline, after 5 days of treatment
measure: Effect of lactoferrin on urinary inflammatory markers.
timeFrame: at baseline, after 5 days of treatment
Secondary outcomes:
measure: To evaluate the efficacy of lactoferrin in the reduction of probable recurrence of Urinary Tract Infection.
timeFrame: 1 month
measure: The number of days of hospitalization.
timeFrame: 1 month
measure: Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects.
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neonate and Infant Pathology, Medical University of Lublin, Poland
name: Ewa Kuźma
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Artym J, Zimecki M. [The role of lactoferrin in the proper development of newborns]. Postepy Hig Med Dosw (Online). 2005;59:421-32. Polish.
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.
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.
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.
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.
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.