The Probiotic E. coli Nissle 1917 Stops Diarrhea in Infants and Toddlers

Background and Objective: The primary goal of treating any form of diarrhea is preventing dehydration and lowering frequency and substantial volumes of stool. Although, in most cases, acute diarrhea (AD) will be self-limiting during the first few days after onset, for neonates and toddlers health risks may arise when diarrhea lasts longer than 3 days. Despite of recent advances, infants diarrhea often tends to become chronic. Patients with prolonged diarrhoea (PD) over 4–14 days are in danger of developing dehydration and an acute deterioration of their general state of health. So far no effective causal therapy exists. Patients and Methods: In two confirmatory, randomized, double-blind clinical trials the efficacy of the probiotic bacterial strain E. coli Nissle 1917 (EcN) as compared to a placebo was tested. In the AD-trial, 113 children (aged 2 to 47 months) with acute diarrhea were randomized to either verum (n=55) or placebo. In the PD-trial, 151 rehydrated children (aged 1 to 47 months) with unspecific prolonged diarrhea (>3 watery or loose stools without blood in 24 hours of a defined diarrhea episode) were randomized to receive either verum (n=75) or placebo for 21 days. Depending on the age of patients 1–3ml per day of verum (suspension with 10E8 viable EcN per ml) or placebo were administered orally. Results: As a reason for the acute diarrhea viral infection was stated in 31% (35/113), bacterial infection in 11.5% (13/113) and mainly unspecific infection in the rest of the children. Onset of the response to treatment (reduction of stool frequency to Conclusion: EcN showed significant superiority compared to placebo in the treatment of acute and prolonged diarrhea in infants and toddlers. This concerns the time to response as well as the response rate which were much more favorable than under self-limiting conditions or placebo.