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J Pediatr. 2013 Feb;162(2):349-56. doi: 10.1016/j.jpeds.2012.07.043. Epub 2012 Aug 30.

Randomized double-blind controlled trial of bovine lactoferrin for prevention of diarrhea in children.

Author information

1
Instituto de Medicina Tropical, Universidad Peruana Cayetano Heredia, Lima, Peru. Theresa.Ochoa@upch.pe

Abstract

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 < .001). There were no adverse events related to the intervention.

CONCLUSIONS:

Although there was no decrease in diarrhea incidence, longitudinal prevalence and severity were decreased with LF.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00560222.

PMID:
22939927
PMCID:
PMC3547155
DOI:
10.1016/j.jpeds.2012.07.043
[Indexed for MEDLINE]
Free PMC Article

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