title: Influence of oral inoculation with plasmid-free human Escherichia coli on the frequency of diarrhea during the first year of life in human newborns.
abstract: BACKGROUND
  This study was carried out to determine whether early inoculation of the plasmid-free human Escherichia coli into human newborns would reduce the frequency of acute diarrhea during a 1-year period. The plasmid-free E. coli strain isolated from the fecal microbiota of a healthy adult was nontoxigenic in vivo and in vitro and sensitive to all usual antibiotics.
  
  
  METHODS
  In the experimental group, 51 healthy newborns were inoculated orally with 106 viable cells of the bacteria within 2 hours after birth. In the control group, the same number of newborns received the heat-killed bacteria. The clinical trial was double blind, and the newborns were randomly assigned to the experimental and control groups.
  
  
  RESULTS
  Six months and 1 year after bacterial inoculation, infants in the experimental group showed a higher mean body weight (7.59 +/- 1.15 kg and 9.88 +/- 1.31 kg, respectively; P < 0.05) when compared with the control group (7.03 +/- 1.09 kg and 8.92 +/- 1.38 kg, respectively). At the end of the clinical trial, 48% (23/48) of the infants in the experimental group had shown at least one diarrhea episode during the 1-year period, as opposed to 71% (34/48) in the control group. These values were significantly different (P = 0.037), showing a 32.3% protective effect of inoculation.
  
  
  CONCLUSIONS
  The present study shows that protection against diarrhea was obtained by oral inoculation with a single dose of plasmid-free human E. coli soon after birth.
authors.affiliation: Departamento de Pediatria, Faculdade de Medicina, Departamento de Bioquímica-Imunologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, 30161-970 Belo Horizonte MG, Brazil.
authors.forename: P P
authors.initials: PP
authors.lastname: Figueiredo
authors.forename: E C
authors.initials: EC
authors.lastname: Vieira
authors.forename: J R
authors.initials: JR
authors.lastname: Nicoli
authors.forename: R D
authors.initials: RD
authors.lastname: Nardi
authors.forename: P
authors.initials: P
authors.lastname: Raibaud
authors.forename: Y
authors.initials: Y
authors.lastname: Duval-Iflah
authors.forename: F J
authors.initials: FJ
authors.lastname: Penna
mesh_terms: D000284:Administration, Oral; D001835:Body Weight; D003968:Diarrhea, Infantile / Q000453:epidemiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004926:Escherichia coli; D004927:Escherichia coli Infections / Q000453:epidemiology / Q000517:prevention & control*; D005243:Feces / Q000382:microbiology; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010957:Plasmids