Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.
NCT ID: NCT06109688
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
55 participants
INTERVENTIONAL
2015-07-01
2018-02-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* the experimental group received bLF
* the control group received placebo without bLF
TREATMENT
QUADRUPLE
Study Groups
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Bovine lactoferrin
Sachets with bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks.
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
Matched sachets with maltodextrin for a period of 4 weeks.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active infection at enrollment, confirmed and documented in medical record.
* Children with Urinary Tract Infection treated according to current recommendations.
Exclusion Criteria
* 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.
7 Days
12 Months
ALL
No
Sponsors
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Pharmabest Sp. z o.o.
INDUSTRY
Medical University of Lublin
OTHER
Responsible Party
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Principal Investigators
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Ewa Kuźma
Role: PRINCIPAL_INVESTIGATOR
Department of Neonate and Infant Pathology, Medical University of Lublin, Poland
References
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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.
Artym J, Zimecki M. [The role of lactoferrin in the proper development of newborns]. Postepy Hig Med Dosw (Online). 2005;59:421-32. Polish.
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.
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.
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.
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.
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.
Other Identifiers
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0254/297/2014
Identifier Type: -
Identifier Source: org_study_id