Randomized Double-Blind Controlled Trial of Bovine Lactoferrin for Prevention of Diarrhea in Children

Objective To determine the effect of bovine lactoferrin (bLF) on prevention of diarrhea in children. Study design We conducted a community-based randomized double-blind placebo controlled trial comparing supplementation with bLF vs placebo. Previously weaned children were enrolled at 12-18 months an...

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Bibliographic Details
Published in:The Journal of pediatrics 2013-02, Vol.162 (2), p.349-356
Main Authors: Ochoa, Theresa J., MD, Chea-Woo, Elsa, MD, Baiocchi, Nelly, MD, Pecho, Iris, MPH, Campos, Miguel, MD, PhD, Prada, Ana, MSc, Valdiviezo, Gladys, RN, Lluque, Angela, MSc, Lai, Dejian, PhD, Cleary, Thomas G., MD
Format: Article
Language:English
Subjects:
Animals
Campylobacter
Cattle
children
compliance
data collection
diarrhea
Diarrhea, Infantile - prevention & control
Double-Blind Method
Escherichia coli
Female
Humans
Infant
lactoferrin
Lactoferrin - therapeutic use
Male
pathogens
Pediatrics
randomized clinical trials
Shigella
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Summary:Objective To determine the effect of bovine lactoferrin (bLF) on prevention of diarrhea in children. Study design We conducted a community-based randomized double-blind placebo controlled trial comparing supplementation with bLF vs placebo. Previously weaned children were enrolled at 12-18 months and followed for 6 months with daily home visits for data collection and supplement administration. Anthropometric measures were done monthly. Results Five hundred fifty-five children were randomized: 277 to bLF and 278 to placebo; 65 dropped out; 147 894 doses were administered (92% compliance). Overall there were 91 446 child-days of observation and 1235 diarrhea episodes lasting 6219 days. The main pathogens isolated during diarrheal episodes were norovirus (35.0%), enteropathogenic E coli (11.4%), Campylobacter (10.6%), enteroaggregative E coli (8.4%), enterotoxigenic E coli (6.9%), and Shigella (6.6%). The diarrhea incidence was not different between groups: 5.4 vs 5.2 episodes/child/year for bLF and placebo, respectively ( P  = .375). However, the diarrhea longitudinal prevalence was lower in the bLF group vs placebo (6.6% vs 7.0%, P  = .017), as well as the median duration of episodes (4.8 vs 5.3 days, P  = .046), proportion of episodes with moderate or severe dehydration (1.0% vs 2.6%, P  = .045), and liquid stools load (95.0 vs 98.6) liquid stools/child/year, P  
ISSN:0022-3476
1097-6833
DOI:10.1016/j.jpeds.2012.07.043