A Phase 3 interventional study of Bovine Lactoferrin and placebo in Urinary Tract Infections in Children, sponsored by Medical University of Lublin. Completed. Open to participants aged 7 Days to 12 Months. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by Medical University of Lublin · Phase 3, Interventional, and Treatment
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.
779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.
This study's enrollment of 55 is below the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Medical University of Lublin is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Sachets with bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks.
Dietary Supplement: Bovine Lactoferrin
Matched sachets with maltodextrin for a period of 4 weeks.
Dietary Supplement: placebo
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
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
Monitoring of parameters of inflammation.
C-reactive protein and procalcitonin levels in both groups. Comparing possible change.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline, after 5 days of treatment
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.
Time frame: 1 month
The number of days of hospitalization.
Length of stay. Comparing possible differences in groups.
Time frame: 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.
Time frame: 1 month
No study locations are listed for this record.
Plan to share: No
Ran from Jul 2015 to primary completion in Dec 2017, 29 months.
Of 36 phase 3 interventional studies under Urinary Tract Infections, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's 29 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lactoferrin, bovine
Medical University of Lublin