Efficacy of the Probiotic Probiotical Confirmed in Acute Gastroenteritis.

ABSTRACT

PURPOSE: Some probiotic strains reduce the duration of acute diarrhea. Because of strain and product specificity, each product needs to be supported by clinical data. This study aimed to test the efficacy of the synbiotic food supplement Probiotical (Streptococcus thermophilus, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium infantis, fructo-oligosaccharides) in children with acute gastroenteritis of likely infectious origin. The primary endpoint was the number of children with normal stool consistency during the treatment duration. METHODS: A total of 46 children (aged 3.6 months to 12 years) with acute gastroenteritis that started less than 48 hours prior to their visit at a hospital-based emergency department were included in this prospective, randomized, placebo-controlled trial. All children were treated with oral rehydration solution and placebo (n=20) or the test product (n=26). RESULTS: Significantly more children had a normal stool consistency on days 1 and 2 in the probiotic group 5 children (20%) on day 1 in the probiotic group compared with none in the placebo group (p=0.046). On day 2, 11 children in the probiotic group (46%) and 3 (16%) in the placebo group (p=0.024) had a normal stool consistency. The mean duration of diarrhea was shorter in the probiotic group compared with that in the placebo group (3.04±1.36 vs. 4.20±1.34 days) (p=0.018). CONCLUSION: The test product was shown to normalize stool consistency significantly more rapidly than the placebo. These data confirm the findings from a previous study in a larger group of children performed in a primary healthcare setting.