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Other therapies

8.5.7 Escherichia coli Nissle 1917

Evidence overview
One multicentre RCT 199 was identified. The study was carried out in 11 paediatric outpatient
centres across Ukraine, Germany and Russia. In total, 113 children aged between 2 and 47 months
with non-bloody acute diarrhoea were randomised into two treatment arms (58 patients in the
probiotic E. coli Nissle 1917 group and 55 in the placebo group) and followed up until treatment
response or to a maximum of 10 days. The participants were allocated into the two groups based
on random numbers. Allocation was such that participants and outcome assessors were unaware
of the treatment given. The authors used an intention-to-treat analysis. The outcomes considered
were duration of diarrhoea, proportion of patients without diarrhoea within the 10th day of
follow-up and adverse events. [EL = 1+]
The baseline comparability between the two groups at the start of the study was adequate, and
12.3% of participants were lost during follow-up. The treatment response was defined as a
reduction in stool frequency to three or fewer watery or loose stools in 24 hours over a period
of at least two consecutive days. When comparing the median duration of diarrhoea between
the two groups, the authors reported that E. coli Nissle 1917 statistically significantly shortened
the duration of diarrhoea by 2.3 days (median duration of diarrhoea in the intervention group
= 2.5 days, median duration of diarrhoea in the control group = 4.8 days). Diarrhoea stopped
within 10 days for 52/55 children in the intervention group and for 39/58 children in the control
group. This difference was statistically significant (RR 1.41; 95% CI 1.16 to 1.70). Two children
in the intervention group (n = 55) suffered from rhinitis and abdominal pain while two children
in the control group (n = 58) had acute otitis media.

Evidence summary

There was evidence form one multicentre RCT conducted in Russia, Ukraine and Germany for
the effectiveness of E. coli Nissle 1917 in the treatment of acute diarrhoea in children. The study
reported that those children receiving E. coli Nissle 1917 probiotic responded to treatment in
a statistically significantly shorter time than those receiving placebo. Diarrhoea had stopped
by day 10 in statistically significantly more children receiving E. coli Nissle 1917 probiotic
compared with the placebo.

GDG translation from evidence to recommendation

There were many studies examining the efficacy of probiotic therapy in children with
gastroenteritis. There was evidence from a high-quality systematic review suggesting that probiotic
treatment had a beneficial effect – shortening the duration of diarrhoea and reducing the stool
frequency. However, the available studies varied in quality, in the specific probiotics studied, in
the treatment regimens used and in the outcomes examined. Therefore, despite some evidence
of possible clinical benefit, the GDG did not consider it appropriate to recommend the use of a
probiotic at this time. This was, however, considered to be an important field for further research.
Licensed preparations of probiotics are not currently available in the NHS.

Research recommendation
Are probiotics effective and safe compared with a placebo in the treatment of children with
gastroenteritis in the UK? Which specific probiotic is most effective and in what specific
treatment regimen?
Why this is important
The available studies of probiotic therapy frequently report benefits, particularly in terms of
reduced duration of diarrhoea or stool frequency. However, most of the published studies
have methodological limitations. Moreover, there is great variation in the specific probiotics
evaluated and in the treatment regimens used. Many of these studies were conducted
in developing countries where the response to probiotic therapy may differ. Good-quality
randomised controlled trials should be conducted in the UK to evaluate the effectiveness and
safety of specific probiotics, using clearly defined treatment regimens and outcome measures.

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