Randomised clinical trial: Lactobacillus reuteri DSM 17938 vs. placebo in children with acute diarrhoea--a double-blind study.

2012-06-11
Alimentary pharmacology & therapeutics 36(4)
- R Francavilla
- E Lionetti
- S Castellaneta
- F Ciruzzi
- F Indrio
- A Masciale
- C Fontana
- M M La Rosa
- L Cavallo
- A Francavilla

PubMed: 22680836
DOI: 10.1111/j.1365-2036.2012.05180.x

Study Design

Type: Randomized Controlled Trial (RCT)
Population: Children (6-36 months), hospitalised in three paediatric hospitals in Southern Italy for acute diarrhoea with clinical signs of dehydration
Methods: Randomised, double-blind, either L. reuteri (dose of 4 × 10^8 colony-forming units/die) or placebo
Blinding: Double-blind

Rigorous Journal

Background

Probiotics may be of help for the management of acute diarrhoea, however, the effect is strain specific and efficacy needs to be proven.

Aim

To test the efficacy and safety of Lactobacillus reuteri DSM 17938 derived from L. reuteri ATCC 55730 in children with acute diarrhoea. Primary outcomes were the rate of unresolved diarrhoea after 3 days of treatment and duration of diarrhoea.

Methods

Children (6-36 months), hospitalised in three paediatric hospitals in Southern Italy for acute diarrhoea with clinical signs of dehydration were randomised to receive in a double-blind fashion either L. reuteri (dose of 4 × 10(8) colony-forming units/die) or placebo.

Results

Out of 96 eligible children, 74 were enrolled, five patients were withdrawn; 35 in the L. reuteri group and 34 in the placebo group. Lactobacillus reuteri significantly reduced the duration of watery diarrhoea as compared with placebo (2.1 ± 1.7 days vs. 3.3 ± 2.1 days; P < 0.03); on day two and three of treatment watery diarrhoea persisted in 82% and 74% of the placebo and 55% and 45% of the L. reuteri recipients respectively (P < 0.01; P < 0.03). Finally, children receiving L. reuteri had a significantly lower relapse rate of diarrhoea (15% vs. 42%; P < 0.03). There was not a significant difference in hospital stay between the groups. No adverse events were recorded.

Conclusion

Our study shows that L . reuteri DSM 17938 as an adjunct to rehydration therapy is efficacious in the treatment of acute diarrhoea reducing the frequency, duration and recrudescence rate of the disease.

Research Insights

Lactobacillus reuteri DSM 17938→Reduced Diarrhea
on day two and three of treatment watery diarrhoea persisted in 82% and 74% of the placebo and 55% and 45% of the L. reuteri recipients respectively (P < 0.01; P < 0.03)
Effect
Beneficial
Effect size
Moderate
Dose
4 × 10^8 colony-forming units/day
Lactobacillus reuteri DSM 17938→Reduced Diarrhea Rate
children receiving L. reuteri had a significantly lower relapse rate of diarrhoea (15% vs. 42%; P < 0.03)
Effect
Beneficial
Effect size
Large
Dose
4 × 10^8 colony-forming units/day
Lactobacillus reuteri DSM 17938→Reduced Duration of Watery Diarrhea
Lactobacillus reuteri significantly reduced the duration of watery diarrhoea as compared with placebo (2.1 ± 1.7 days vs. 3.3 ± 2.1 days; P < 0.03)
Effect
Beneficial
Effect size
Moderate
Dose
4 × 10^8 colony-forming units/day
Lactobacillus reuteri DSM 17938→Reduced Hospital Stay
There was not a significant difference in hospital stay between the groups.
Effect
Neutral
Effect size
Small
Dose
4 × 10^8 colony-forming units/day

Adverse Events Reported

Lactobacillus reuteri DSM 17938→Overall tolerability
No adverse events were recorded.
Finding
Reported