Page 155 - 15Diarrhoeaandvomiting

Diarrhoea and vomiting caused by gastroenteritis in children under 5 years

was statistically significant favouring the intervention group (WMD −2.95; 95% CI −3.4 to −0.6).
One trial reported two cases of myoclonic jerks (one case in each study group) and another trial
reported no adverse events.

Evidence summary
There was evidence from a well-conducted systematic review [EL = 1+] for the effectiveness of
Lactobacillus rhamnosus GG in children suffering from acute diarrhoea. Data from seven trials
were combined, showing that children treated with Lactobacillus rhamnosus GG experienced a
1 day reduction in the duration of diarrhoea but there was significant statistical heterogeneity.
Analysis performed on total stool output and hospitalisation showed no statistically significant
difference between children receiving Lactobacillus rhamnosus GG and children that did not
receive the probiotic.

8.5.3 Lactobacillus acidophilus LB

Evidence overview
201
One RCT was identified for inclusion. This study, conducted in Peru, randomised a total of 80
children with acute diarrhoea presumed to be of infectious origin into two treatment arms (40
participants in each group). Children with signs of dehydration requiring hospitalisation and those
with illnesses other than the acute diarrhoeal episode were excluded. Lactobacillus acidophilus
LB administration over 4.5 days was compared with placebo. Methods of randomisation and
allocation concealment were unclear although the study was stated to be double-blind. [EL = 1+].
The baseline comparability of the two groups at the start of the study was adequate. Three
participants out of 80 were lost to follow-up. No statistically significant differences were observed
between the two groups for any of the outcomes considered, which were duration of diarrhoea,
proportion of children with diarrhoea at the end of the study, total ORS solution intake and
vomiting. One child in the probiotic group had severe dehydration and was withdrawn from the
study and another child from the placebo group developed an itchy rash.

Evidence summary
An RCT located in Peru [EL = 1+] examined the effectiveness of Lactobacillus acidophilus LB
in the treatment of acute diarrhoea in children. It showed no statistically significant differences
between the probiotic group and the placebo group when considering duration of diarrhoea,
ORS solution total intake, vomiting, adverse events and proportion of children without diarrhoea
by the end of the study.

8.5.4 Lactobacillus paracasei strain ST11

Evidence overview
One RCT conducted in Bangladesh was identified. 200 In total, 230 male infants and young
children aged 4–24 months in the course of diarrhoea of less than 48 hours’ duration were
randomly divided into two treatment arms to evaluate the therapeutic benefit of administering
lyophilised Lactobacillus paracasei strain ST11 (n = 115) compared with placebo (n = 115) for
5 days. Children with bloody diarrhoea, with severe malnutrition or requiring antibiotic therapy
were excluded. Children whose stool sample resulted positive for Vibrio cholerae were also
excluded. The method of randomisation and allocation concealment were adequate. The trial was
performed double-blind. The outcomes measured were mean duration of diarrhoea, cessation of
diarrhoea, total stool output and total ORS solution intake. Participants were followed in hospital
for 6 days or until cessation of diarrhoea. [EL = 1+]
The baseline comparability of the two groups under study was adequate.and the loss to follow-up
was 11.8%. There were no statistically significant differences in the findings for the two groups
for the mean duration of diarrhoea, the proportion of children without diarrhoea by the end of
the 6th day, the mean total stool output and the mean total ORS solution. Findings for children
requiring IV fluids were not statistically significantly different overall and for rotavirus-infected
(n = 130) children. However, when non-rotavirus-infected children were considered (n = 63),

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