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Randomised clinical trial: Lactobacillus reuteri DSM 17938 vs. placebo in children with acute diarrhoea--a
R Francavilla1, E Lionetti, S Castellaneta
1Department of Biomedicina dell'Età Evolutiva, University of Bari, Piazza Giulio Cesare 11, Bari, Italy. rfrancavilla@me.com
Insights
Lactobacillus reuteri DSM 17938 effectively treats acute childhood diarrhea by reducing duration, frequency, and recurrence. This probiotic is a safe and beneficial adjunct to rehydration therapy.
Area of Science:
- Pediatric Gastroenterology
- Microbiology
- Clinical Therapeutics
Background:
- Probiotics show potential for acute diarrhea management, but efficacy is strain-specific.
- Strain-specific efficacy necessitates rigorous clinical validation for probiotic interventions.
Purpose of the Study:
- To evaluate the efficacy and safety of Lactobacillus reuteri DSM 17938 in children with acute diarrhea.
- Primary endpoints included unresolved diarrhea rates and duration of illness.
Main Methods:
- A double-blind, randomized controlled trial was conducted in hospitalized children aged 6-36 months with acute diarrhea and dehydration.
- Participants received either Lactobacillus reuteri DSM 17938 (4 × 10^8 CFU/day) or a placebo as an adjunct to rehydration therapy.
Main Results:
- Lactobacillus reuteri significantly reduced the duration of watery diarrhea compared to placebo (2.1 vs. 3.3 days, P < 0.03).
- Fewer children in the Lactobacillus reuteri group experienced persistent watery diarrhea on days two and three (45-55% vs. 74-82%, P < 0.01-0.03).
- The probiotic group demonstrated a significantly lower relapse rate of diarrhea (15% vs. 42%, P < 0.03) with no recorded adverse events.
Conclusions:
- Lactobacillus reuteri DSM 17938 is efficacious as an adjunct therapy for acute diarrhea in children.
- The probiotic significantly reduces diarrhea frequency, duration, and recrudescence.
- Lactobacillus reuteri DSM 17938 is a safe and effective treatment option for pediatric acute diarrhea.
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.
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