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0 0.5 1 1.5 2+ Case 50% Improvement Relative Risk Lactoferrin  Pasinato et al.  Prophylaxis  RCT Does lactoferrin reduce COVID-19 infections? RCT 50 patients in Italy Trial underpowered to detect differences Pasinato et al., Children, February 2024 Favors lactoferrin Favors control

Lactoferrin in the Prevention of Recurrent Respiratory Infections in Preschool Children: A Prospective Randomized Study

Pasinato et al., Children, doi:10.3390/children11020249
Feb 2024  
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RCT 50 preschool children, 25 treated with bovine lactoferrin (bLf) prophylaxis, showing significantly lower frequency and duration of respiratory infections during the active phase with treatment. The only COVID-19 specific results reported are the number as patients with COVID, 1 vs. 2 for treatment vs. control. bLf 400mg bid for 4 months.
risk of case, 50.0% lower, RR 0.50, p = 1.00, treatment 1 of 25 (4.0%), control 2 of 25 (8.0%), NNT 25.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Pasinato et al., 15 Feb 2024, Randomized Controlled Trial, Italy, peer-reviewed, mean age 4.2, 5 authors. Contact: (corresponding author),,,,
This PaperLactoferrinAll
Lactoferrin in the Prevention of Recurrent Respiratory Infections in Preschool Children: A Prospective Randomized Study
Angela Pasinato, Mario Fama, Giovanni Tripepi, Colin Gerard Egan, Eugenio Baraldi
Children, doi:10.3390/children11020249
Few studies have evaluated the effect of bovine lactoferrin (bLf) on reducing respiratory infections in preschool children. This randomized controlled trial evaluated the effect of bLf in preschool children with recurrent respiratory infections. Participants were randomly assigned bLf (n = 25) or control (n = 25). Outcomes included respiratory infection episodes (RIEs), symptom duration, school absence and medication. Fifty children aged 4.2 ± 0.1 years were included. During the active 4-month phase, median number of RIEs was reduced by 50% in the bLf group [1-episode, interquartile range (IQR): 0-2] vs. control (2, IQR: 1-3; p = 0.02). The proportion of participants with >3 RIEs was significantly lower in bLf (n = 1, 4%) vs. control (n = 7, 28%) with 80% lower odds of upper RIEs in the bLf arm (odds ratio: 0.20, 95% CI:0.06-0.74, p = 0.015). The duration of symptoms (3 vs. 6, p = 0.009) and days absent from school (3 vs. 6, p = 0.15) were lower in the active arm. Over the 2-month follow-up, no significant differences were observed between groups for infection episodes, symptom duration or school absence. However, bLf-treated children received significantly less corticosteroids over the entire 6-month study period (32% vs. 60%; p = 0.047). bLf supplementation significantly reduced the frequency and duration of RIEs in children with decreased corticosteroid use.
Funding: No funding was obtained for the undertaking of this non-profit study. Pharmaguida Srl supplied lactoferrin for the treatment of children for the entire duration of the study. No commercial entity was involved in data collection, analysis and interpretation of results. Institutional Review Board Statement: The study was approved on 28/10/2022 by the Ethics Committee per le Sperimentazioni Cliniche della Provincia di Vicenza, Italy (Protocol number 113083). This study was performed in accordance to the ethical standards laid down in the 1975 Declaration of Helsinki. Informed Consent Statement: Parents or guardians provided written informed consent. Conflicts of Interest: The authors declare no conflicts of interest.
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