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| Name | Class |
|---|---|
| Pharmabest Sp. z o.o. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bovine lactoferrin | Experimental | Sachets with bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks. |
|
| Placebo | Placebo Comparator | Matched sachets with maltodextrin for a period of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The number of days of hospitalization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewa Kuźma | Department of Neonate and Infant Pathology, Medical University of Lublin, Poland | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29694997 | Background | 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. | |
| 16106243 | Background |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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patients with Urinary Tract Infections were recruited subjects were randomized into two groups:
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|
| 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. |
|
|
Length of stay. Comparing possible differences in groups. |
| 1 month |
| 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 |
| Artym J, Zimecki M. [The role of lactoferrin in the proper development of newborns]. Postepy Hig Med Dosw (Online). 2005;59:421-32. Polish. |
| 29292282 | 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. |
| 25828291 | 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. |
| 23389820 | 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. |
| 27833443 | 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. |
| 22495097 | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |