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

Background: Some probiotic strains reduce the duration of acute diarrhoea. As a result of strain and product specificity, each product needs support by clinical data.

Aim: 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.

Method: 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).

Results: 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.

Conclusion: 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.