RANDOMISED CLINICAL TRIAL
Randomised clinical trial: efficacy of a new synbiotic formulation containing Lactobacillus paracasei B21060 plus arabinogalactan and xilooligosaccharides in children with acute diarrhoea
Article first published online: 13 FEB 2012
© 2012 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 35, Issue 7, pages 782–788, April 2012
How to Cite
Passariello, A., Terrin, G., Cecere, G., Micillo, M., De Marco, G., Di Costanzo, M., Cosenza, L., Leone, L., Nocerino, R. and Berni Canani, R. (2012), Randomised clinical trial: efficacy of a new synbiotic formulation containing Lactobacillus paracasei B21060 plus arabinogalactan and xilooligosaccharides in children with acute diarrhoea. Alimentary Pharmacology & Therapeutics, 35: 782–788. doi: 10.1111/j.1365-2036.2012.05015.x
- Issue published online: 8 MAR 2012
- Article first published online: 13 FEB 2012
- Manuscript Accepted: 19 JAN 2012
- Manuscript Revised: 14 JAN 2012
- Manuscript Revised: 21 SEP 2011
- Manuscript Received: 8 SEP 2011
Acute diarrhoea is a frequent problem in children with heavy economic burden for families and society.
To test the efficacy of a new synbiotic formulation containing Lactobacillus paracasei B21060, arabinogalactan and xilooligosaccharides in children with acute diarrhoea.
Double-blind, randomised, placebo-controlled trial, including children (age 3–36 m) with acute diarrhoea who were allocated to placebo or synbiotic group. Major outcome was resolution rate of diarrhoea at 72 h. Total duration of diarrhoea, daily stool outputs, stool consistency, working days lost by parents, adjunctive medications, and hospitalisation were also assessed.
We enrolled 55 children in placebo group and 52 in synbiotic group. The two groups were similar for demographic and clinical characteristics. Resolution rate of diarrhoea at 72 h was significantly higher in synbiotic group (67%) compared to placebo group (40%, P = 0.005). Children in synbiotic group showed a significant reduction in the duration of diarrhoea (90.5 h, 78.1–102.9 vs. 109.8 h, 96.0–123.5, P = 0.040), daily stool outputs (3.3, 2.8–3.8 vs. 2.4, 1.9–2.8, P = 0.005) and stool consistency (1.3, 0.9–1.6 vs. 0.6, 0.4–0.9, P = 0.002) compared to placebo group (data expressed as mean, 95% CI). Rate of parents that missed at least one working day (41.8% vs. 15.4%, P = 0.003), rate of children that needed adjunctive medications (25.5% vs. 5.8%, P = 0.005) or hospitalisation (10.9% vs. 0%, P = 0.014) after the first 72 h of treatment, were reduced in synbiotic group.
The synbiotic formulation studied is effective in children with acute diarrhoea. Australian New Zealand Clinical Trials Registry (ACTRN12611000641998).