Page 156 - 15Diarrhoeaandvomiting

Other therapies

the probiotic showed a statistically significant positive effect in reducing the total ORS solution
intake and the stool output, and in increasing the number of patients with resolution of diarrhoea
by the end of follow-up.

Evidence summary
An RCT conducted in Bangladesh [EL = 1+] evaluated the effectiveness of Lactobacillus paracasei
strain ST11 in the management of acute diarrhoea in children. The study found no statistically
significant differences between children treated with the probiotic and children that received
placebo regarding the duration of diarrhoea, the total stool output, the total ORS solution intake,
the number of children without diarrhoea by the end of the study or the number of children
requiring IV fluids. However, they found the probiotic to have a clinical benefit when considering
data from non-rotavirus-infected children only.

8.5.5 Lactobacillus rhamnosus strains 573L/1, 573L/2 and 573L/3

Evidence overview
40
One RCT was identified for inclusion. This trial, conducted in Poland, randomised a total of
93 children aged between 2 months and 6 years with acute diarrhoea into two treatment arms
to assess the effectiveness of administering Lactobacillus rhamnosus strains 573L/1, 573L/2 and
573L/3 for 5 days compared with placebo. Patients with chronic diseases, immunosuppressive
conditions or exclusively breastfed were excluded. Methods of randomisation and allocation
concealment were adequate. Investigators and patients were blinded to the treatment. The
outcomes considered were duration of diarrhoea, diarrhoea lasting more than 7 days, IV therapy
and adverse events. [EL = 1+]
The baseline comparability of the two groups was adequate and more than 90% of the enrolled
participants were included in the study analysis. The study found that the duration of diarrhoea
was not statistically significantly different between the treatment (n = 46) and placebo (n = 41)
groups. In rotavirus-infected patients (n = 39), children treated with the probiotic had a statistically
significant shorter duration of diarrhoea (n = 22, mean 77.5 hours, SD 35.4 hours) than children
that received placebo (n = 17, mean 115.0 hours, SD 66.9 hours) (WMD −37.5 hours; 95% CI
−72.6 to −2.4 hours).
The difference in the proportions of cases of diarrhoea lasting more than 7 days in each group
was not statistically significant. On admission, children were rehydrated per os or intravenously
according to ESPGHAN recommendations. The authors reported that the mean duration of
parenteral rehydration required was not statistically significantly different between the two
treatment groups. The duration of parenteral rehydration required was statistically significantly
shorter among children treated with the probiotic (n = 22, mean 14.9 hours, SD 13.7 hours)
when compared with children receiving placebo (n = 17, mean 37.7 hours, SD 32.9 hours). This
difference between the two groups was statistically significant (WMD −22.8 hours; 95% CI −39.5
to −6.2 hours). No adverse events were reported.

Evidence summary

An RCT located in Poland showed no statistically significant differences between the children
receiving a probiotic preparation of Lactobacillus rhamnosus strains 573L/1, 573L/2 and 573L/3
and the children receiving placebo. When only rotavirus-infected children were considered, the
trial showed a statistically significant clinical benefit of the probiotic in reducing the duration of
diarrhoea and the duration of the IVT required.

8.5.6 Saccharomyces boulardii
One systematic review 198 evaluated the therapeutic effects of Saccharomyces boulardii in the
treatment of acute diarrhoea in children. The review included five RCTs involving a total of 619
participants. Of these RCTs, two were located in Pakistan, one in Mexico, one in Turkey and
one in Argentina. The participants were children aged between 2 months and 12 years suffering
from diarrhoea. The systematic review was well conducted. However, all the studies included
had methodological limitations: only two trials reported an adequate method of randomisation,

131