Randomised clinical trial: the synbiotic food supplement Probiotical vs. placebo for acute gastroenteritis in children

Abstract

Some probiotic strains reduce the duration of acute diarrhoea. As a result of strain and product specificity, each product needs support by clinical data. In children with acute diarrhoea, to test the efficacy of the synbiotic food supplement Probiotical (Streptoccoccus thermophilus, Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium infantis, fructo-oligosaccharides). The primary end-points were duration of diarrhoea and the number of children that had a normalised stool consistency. A total of 111 children with acute diarrhoea (median age 40 months) were included in this randomised, prospective placebo-controlled parallel clinical trial in primary health care. All children were treated with oral rehydration solution ad libitum and with the synbiotic (n=57) or placebo (n = 54). The median duration of diarrhoea was 3 days (IQ 25-75: 2-4 days) in the Probiotical group, compared with 4 days (IQ 25-75: 4-5 days) in the placebo group (P<0.005). The number of children with normal stool consistency (defined as stool Bristol score ≤4) was higher in the synbiotic group on days 2 and 3 [21 vs. 2% (P<0.001) and 50 vs. 24% (P<0.001) respectively]. Less additional medication (antipyretics, antiemetics, antibiotics) was administered in the synbiotic group. Physicians were globally more satisfied with the synbiotic food supplement treatment than with placebo (P=0.005). One patient in the placebo group was hospitalised. The median duration of diarrhoea was significantly 1 day shorter in the synbiotic than in the placebo group, associated with decreased prescription of additional medications.