Efficacy of Lactobacillus reuteri DSM 17938 in Thai children with acute gastroenteritis and normal or mild dehydration in an outpatient setting: a randomized controlled trial.

2025-06-07
Journal of tropical pediatrics 71(4)
- Lakkana Rerksuppaphol
- Sanguansak Rerksuppaphol

PubMed: 40618229
DOI: 10.1093/tropej/fmaf027

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 48
Population: children with acute diarrhoea
Methods: A randomized double-blind controlled trial; eligible children were randomly allocated to receive either L. reuteri 1 × 10^8 colony-forming units or a placebo for 5 days.

Lactobacillus reuteri DSM 17938 (L. reuteri) has been recommended for treating acute diarrhoea; however, literature data about its efficacy are scarce and controversial. This study investigated the effectiveness of L. reuteri supplementation on the treatment outcome of children with acute diarrhoea. A randomized double-blind controlled trial was conducted in children with acute diarrhoea who attended the outpatient clinic of Srinakharinwirot University Hospital, Thailand. Eligible children were randomly allocated to receive either L. reuteri 1 × 108 colony-forming units or a placebo for 5 days. The primary outcome was the time diarrhoea was resolved. Of the 48 participants (23 in L. reuteri and 25 in the placebo group), 29 (60.4%) were male and the mean age (range) was 12.3 months (1-26 months). The median time for diarrhoea to be resolved was significantly shorter in the L. reuteri group compared to the control (48 and 60 h, respectively, P-value = .042). The percentage of participants who recovered within 48 h was significantly higher in the L. reuteri group (65.2%) compared to the control group (36.0%) [relative risk (RR) 3.33, 95% confidence interval (CI) 1.02-10.89, P-value = .043]. The percentage of participants who recovered from diarrhoea within 72 h was 87.0% and 60%, respectively, [RR 4.44, 95% CI 1.04-19.0, P-value = .036]. No persistent diarrhoea or severe adverse effects were observed in both groups.The use of L. reuteri DSM 17938 as an adjunct therapy led to a significantly shorter duration of diarrhoea in children with acute diarrhoea.

Research Insights

Lactobacillus reuteri DSM 17938→Improved Recovery from Diarrhoea
The percentage of participants who recovered from diarrhoea within 72 h was 87.0% and 60%, respectively, [RR 4.44, 95% CI 1.04-19.0, P-value = .036].
Effect
Beneficial
Effect size
Large
Dose
1 × 10^8 CFU/day
Lactobacillus reuteri DSM 17938→No Serious Adverse Effects
No persistent diarrhoea or severe adverse effects were observed in both groups.
Effect
Neutral
Effect size
Small
Dose
1 × 10^8 CFU/day
Lactobacillus reuteri DSM 17938→Reduced Diarrhea Rate
The percentage of participants who recovered within 48 h was significantly higher in the L. reuteri group (65.2%) compared to the control group (36.0%) [relative risk (RR) 3.33, 95% confidence interval (CI) 1.02-10.89, P-value = .043].
Effect
Beneficial
Effect size
Moderate
Dose
1 × 10^8 CFU/day
Lactobacillus reuteri DSM 17938→Reduced Duration of Diarrhea
The median time for diarrhoea to be resolved was significantly shorter in the L. reuteri group compared to the control (48 and 60 h, respectively, P-value = .042).
Effect
Beneficial
Effect size
Moderate
Dose
1 × 10^8 CFU/day
Lactobacillus reuteri DSM 17938→Reduced Recovery Time for Diarrhea
The percentage of participants who recovered from diarrhoea within 72 h was 87.0% and 60%, respectively, [RR 4.44, 95% CI 1.04-19.0, P-value = .036].
Effect
Beneficial
Effect size
Moderate
Dose
1 × 10^8 CFU/day

Adverse Events Reported

Lactobacillus reuteri DSM 17938→Overall tolerability
No persistent diarrhoea or severe adverse effects were observed in both groups.
Finding
Reported