Efficacy and Safety of Saccharomyces boulardii in Acute Rotavirus Diarrhea: Double Blind Randomized Controlled Trial from a Developing Country.

2016-06-09
Journal of tropical pediatrics 62(6)
- Susrut Das
- Pradeep Kumar Gupta
- Rashmi Ranjan Das

PubMed: 27283364
DOI: 10.1093/tropej/fmw032

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 60
Population: 60 children with acute rotavirus diarrhea
Methods: Randomized, intervention group received Saccharomyces boulardii (500 mg/day) for 5 days
Duration: 5 days
Funding: Unclear

Objective

To study the efficacy and safety of Saccharomyces boulardii (SB) in acute childhood rotavirus diarrhea.

Methods

Children (3 months to 5 years) with WHO-defined acute watery diarrhea and stool rotavirus positive (n = 60) were randomized into intervention (n = 30) and control (n = 30) groups. The intervention group received SB (500 mg/day) for 5 days.

Results

The median duration (hours) of diarrhea was significantly shorter in the intervention group (60 vs. 89; 95% CI: -41.2 to - 16.8). A significantly shorter duration of hospitalization (74 vs. 91; 95% CI: -33.46 to - 0.54) was also seen in the intervention group, but no significant difference was seen for fever and vomiting. There was also no difference between the two groups in the proportion of children requiring parenteral rehydration and persistence of diarrhea lasting beyond day 7. There was no report of any adverse events.

Conclusions

The present trial showed that SB is effective and safe in acute rotavirus diarrhea.

Research Insights

saccharomyces boulardii→Reduced Diarrhea Rate
and persistence of diarrhea lasting beyond day 7
Effect
Neutral
Effect size
Small
Dose
500 mg/day for 5 days
saccharomyces boulardii→Reduced Fever
no significant difference was seen for fever and vomiting
Effect
Neutral
Effect size
Small
Dose
500 mg/day for 5 days
saccharomyces boulardii→Reduced Hospitalization Duration
A significantly shorter duration of hospitalization (74 vs. 91; 95% CI: -33.46 to -0.54) was also seen in the intervention group
Effect
Beneficial
Effect size
Moderate
Dose
500 mg/day for 5 days
saccharomyces boulardii→Reduced Need for Parenteral Rehydration
There was also no difference between the two groups in the proportion of children requiring parenteral rehydration
Effect
Neutral
Effect size
Small
Dose
500 mg/day for 5 days
saccharomyces boulardii→Reduced Vomiting
no significant difference was seen for fever and vomiting
Effect
Neutral
Effect size
Small
Dose
500 mg/day for 5 days

Adverse Events Reported

saccharomyces boulardii→Overall tolerability
There was no report of any adverse events.
Finding
Reported