Probiotic Escherichia coli Nissle 1917 versus placebo for treating diarrhea of greater than 4 days duration in infants and toddlers.
BACKGROUND
Administering probiotics can prevent or cure some forms of diarrhea. The efficacy of probiotic Escherichia coli Nissle 1917 (EcN) in infants and toddlers with diarrhea >4 days was tested by a double-blind trial.


METHODS
One hundred fifty-one children aged 1-47 months with nonspecific diarrhea were randomized to receive either EcN suspension (N = 75) or placebo (N = 76). Diarrhea had to meet the following definition: >3 watery or loose nonbloody stools in 24 hours of a diarrheal episode persisting for >4 consecutive days but < or =14 days. All children were well nourished or only moderately malnourished, mildly dehydrated, and received oral rehydration at study commencement. They were treated orally with 1-3 mL EcN suspension (1 mL contains 10 viable cells) or placebo daily for 21 days. Primary objective was to confirm a better response rate (reduction of daily stool frequency to < or =3 watery or loose stools over > or =4 days) with EcN.


RESULTS
The 7-day response was higher for the EcN group than placebo (EcN 78.7%, placebo 59.2%). Significant differences were observed on days 14 (EcN 93.3%, placebo 65.8%, P = 0.0017) and 21 (EcN 98.7%, placebo 71.1%, P < 0.001). Kaplan-Meier survival analysis resulted in a significant difference of 3.3 days between the groups (P < 0.0001); median time to response for EcN was 2.4 and 5.7 for placebo. EcN was safe and well tolerated.


CONCLUSIONS
In the conditions of this trial EcN was a suitable remedy for diarrhea >4 days in young children.
Henker
Jobst
J
Department of Pediatrics, University Carl-Gustav-Carus, Dresden, Germany. Jobst.Henker@uniklinikum-dresden.de
Laass
Martin W
MW
Blokhin
Boris M
BM
Maydannik
Vitaliy G
VG
Bolbot
Yuriy K
YK
Elze
Martina
M
Wolff
Corinna
C
Schreiner
Armin
A
Schulze
Jürgen
J
D002675:Child, Preschool; D003967:Diarrhea / Q000628:therapy*; D004311:Double-Blind Method; D004926:Escherichia coli; D006801:Humans; D007223:Infant; D053208:Kaplan-Meier Estimate; D019936:Probiotics / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome