Original ArticleRandomized Double-Blind Controlled Trial of Bovine Lactoferrin for Prevention of Diarrhea in Children
Section snippets
Methods
A community-based randomized double blind placebo-controlled trial was conducted in children from Lima, Peru, comparing twice daily supplementation with bLF vs placebo administered for 6 months with monitoring of diarrhea and growth.
Eligible children were previously weaned at 12-18 months old. Exclusion criteria were a history of severe, persistent, or chronic diarrhea, severe malnutrition, serious infections requiring hospitalization in the month prior, serious chronic illness, or a personal
Results
The study was conducted from January 2008 through May 2011. The census of 52 144 households found 3674 children in the targeted age range. The food-intake survey found 2495 children still breastfeeding (67.9%) leaving 1179 eligible children (Figure). A lower than expected enrollment rate together with a much lower than expected drop out rate and much higher than expected illness rate, resulted in 555 rather than 602 children enrolled; 277 were randomized to bLF and 278 to placebo. Eighty-nine
Discussion
This study failed to achieve its primary objective of demonstrating decreased incidence of diarrheal disease with bLF as well as the secondary objective of demonstrating improved growth. However, measures of severity were positively affected although the benefit was small. The data suggest that chronic use of bLF such as is currently done in some infant formulas is unlikely to have a major impact on diarrhea in children. LF without other breast milk factors may have limited value. LF might have
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Funded by National Institute of Child Health and Human Development, USA (Public Health Service award R01-HD051716). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Child Health and Human Development or the National Institutes of Health. The authors declare no conflicts of interest.
Registered at ClinicalTrials.gov: NCT00560222