A randomised, double blind, placebo-controlled, multi-centre study to evaluate the efficacy of L. reuteri DSM 17938 (Protectis) in prevention of nosocomial diarrhoea in children admitted to hospital for reasons other than diarrhoea, aged 1-48 months. 91 children were given L. reuteri and 93 the equivalent placebo for the length of the hospital stay.
L. reuteri did not affect the incidence of hospital-acquired diarrhoeal disease. In addition, there was no difference between the L. reuteri and placebo groups for any of the secondary outcomes, including adverse effects. Rotavirus vaccination status had no impact on the results.
The trial did not find any preventive effect of L. reuteri in the dosage of 10^9 CFU/day compared to placebo.
This was a repeat of the Wanke trial of 2012, but with a 10 times higher dose = 10^9 CFU/day. The baseline incidence of nosocomial diarrhoea in this high dose trial became however much lower than estimated, 7% instead of 33%, and consequently the number of included and analysed subjects in the trial became too low to be able to detect any statistically significant differences between the two groups. Therefore it is still an open question whether this dosage may work for this indication.