Clinical trial: effectiveness of Lactobacillus rhamnosus (strains E/N, Oxy and Pen) in the prevention of antibiotic-associated diarrhoea in children.
BACKGROUND
Convincing evidence that probiotic administration can lower the risk of antibiotic-associated diarrhoea is limited to certain micro-organisms.


OBJECTIVE
To determine the efficacy of administration of Lactobacillus rhamnosus (strains E/N, Oxy and Pen) for the prevention of antibiotic-associated diarrhoea in children.


METHODS
Children (aged 3 months to 14 years) with common infections were enrolled in a double-blind, randomized, placebo-controlled trial in which they received standard antibiotic treatment plus 2 x 10(10) colony forming units of a probiotic (n = 120) or a placebo (n = 120), administered orally twice daily throughout antibiotic treatment. Analyses were by intention to treat.


RESULTS
Any diarrhoea (>or=3 loose or watery stools/day for >or=48 h occurring during or up to 2 weeks after the antibiotic therapy) occurred in nine (7.5%) patients in the probiotic group and in 20 (17%) patients in the placebo group (relative risk, RR 0.45, 95% confidence interval, CI 0.2-0.9). Three (2.5%) children in the probiotic group developed AAD (diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea) compared to nine (7.5%) in the placebo group (RR 0.33, 95% CI 0.1-1.06). No adverse events were observed.


CONCLUSIONS
Administration of L. rhamnosus (strains E/N, Oxy and Pen) to children receiving antibiotics reduced the risk of any diarrhoea, as defined in this study.
Ruszczyński
M
M
2nd Department of Pediatrics, The Medical University of Warsaw, Warsaw, Poland.
Radzikowski
A
A
Szajewska
H
H
D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003967:Diarrhea / Q000139:chemically induced / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D052201:Lacticaseibacillus rhamnosus; D008297:Male; D019936:Probiotics; D011379:Prognosis; D012307:Risk Factors
D000900:Anti-Bacterial Agents