title: Randomized double-blind controlled trial of bovine lactoferrin for prevention of diarrhea in children.
abstract: OBJECTIVE
  To determine the effect of bovine lactoferrin (bLF) on prevention of diarrhea in children.
  
  
  METHODS
  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.
authors.affiliation: Instituto de Medicina Tropical, Universidad Peruana Cayetano Heredia, Lima, Peru. Theresa.Ochoa@upch.pe
authors.forename: Theresa J
authors.initials: TJ
authors.lastname: Ochoa
authors.forename: Elsa
authors.initials: E
authors.lastname: Chea-Woo
authors.forename: Nelly
authors.initials: N
authors.lastname: Baiocchi
authors.forename: Iris
authors.initials: I
authors.lastname: Pecho
authors.forename: Miguel
authors.initials: M
authors.lastname: Campos
authors.forename: Ana
authors.initials: A
authors.lastname: Prada
authors.forename: Gladys
authors.initials: G
authors.lastname: Valdiviezo
authors.forename: Angela
authors.initials: A
authors.lastname: Lluque
authors.forename: Dejian
authors.initials: D
authors.lastname: Lai
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Cleary
mesh_terms: D000818:Animals; D002417:Cattle; D003968:Diarrhea, Infantile / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007781:Lactoferrin / Q000627:therapeutic use*; D008297:Male
chemical_list: D007781:Lactoferrin