Effect of preventive administration of a nonpathogenic Escherichia coli strain on the colonization of the intestine with microbial pathogens in newborn infants.

In a randomized, double-blind study, 27 healthy newborn infants were colonized with the nonpathogenic Escherichia coli strain Nissle 1917 (E. coli DSM 6601, Mutaflor) during the first 5 days of life by daily oral inoculation of 1 ml of a suspension with 10(8) living cells. A second group of 27 newborns, used as controls, received a placebo suspension (1 ml of phosphate-buffered saline) instead. Stool samples were taken on days 1, 2, 3, 5, and 21, and 6 months after birth. All samples were examined for the presence of the nonpathogenic E. coli strain and of pathogenic and potentially pathogenic microorganisms. The administered E: coli strain was detected in the stools of the colonized newborns from day 2 and remained present throughout the study in more than 90% of these infants. Colonization with true and potential bacterial pathogens was significantly reduced in infants receiving E. coli strain Nissle 1917 compared to the placebo group--both with respect to numbers of pathogens and to the spectrum of species.

RCT Entities:   Population Interventions Outcomes