- 2015-02-10
- Clinical pediatrics 54(12)
- Stephen B Freedman
- Philip M Sherman
- Andrew Willan
- David Johnson
- Serge Gouin
- Suzanne Schuh
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- children aged 4 to 48 months with gastroenteritis
- Methods
- 3-site, double-blind, placebo-controlled study; randomized to receive 5 days of placebo, low-dose (4 × 10^9 colony forming units per day), or high-dose (8 × 10^9 colony forming units per day) probiotic (Lactobacillus helveticus and Lactobacillus rhamnosus) in a 2:1:1 ratio
- Blinding
- Double-blind
- Duration
- 5 days
Background
Benefits associated with probiotic administration to children seeking emergency department care with diarrheal disease are unknown.Methods
In this 3-site, double-blind, placebo-controlled study, children aged 4 to 48 months with gastroenteritis were randomized to receive 5 days of placebo, low-dose (4 × 10(9) colony forming units per day), or high-dose (8 × 10(9) colony forming units per day) probiotic (Lactobacillus helveticus and Lactobacillus rhamnosus) in a 2:1:1 ratio. The primary outcome was day care absenteeism.Results
The proportion of children missing a day of day care was 63% (39/62) and 61% (37/61) in the placebo and probiotic arms, respectively (95%CI -14.6% to 18.9%). The proportions experiencing unscheduled health care provider visits and intravenous fluid rehydration were 24% (15/62), 7% (4/62), and 30% (18/61), 5% (3/61) in the placebo and probiotic study arms, respectively (P = .52 and P = .65). None of the results differed based on probiotic dose.Conclusions
The probiotic evaluated did not reduce absenteeism. Since power was suboptimal, further evaluation is required.