Randomised clinical trial: efficacy of a new synbiotic formulation containing Lactobacillus paracasei B21060 plus arabinogalactan and xilooligosaccharides in children with acute diarrhoea.
BACKGROUND
Acute diarrhoea is a frequent problem in children with heavy economic burden for families and society.


OBJECTIVE
To test the efficacy of a new synbiotic formulation containing Lactobacillus paracasei B21060, arabinogalactan and xilooligosaccharides in children with acute diarrhoea.


METHODS
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.


RESULTS
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.


CONCLUSIONS
The synbiotic formulation studied is effective in children with acute diarrhoea. Australian New Zealand Clinical Trials Registry (ACTRN12611000641998).
Department of Paediatrics, University of Naples "Federico II", Italy.
A
A
Passariello
G
G
Terrin
G
G
Cecere
M
M
Micillo
G
G
De Marco
M
M
Di Costanzo
L
L
Cosenza
L
L
Leone
R
R
Nocerino
R Berni
RB
Canani
D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D003968:Diarrhea, Infantile / Q000191:economics / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005685:Galactans / Q000008:administration & dosage*; D005965:Glucuronates / Q000008:administration & dosage*; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007778:Lactobacillus; D008297:Male; D009844:Oligosaccharides / Q000008:administration & dosage*; D010290:Parents / Q000523:psychology; D011446:Prospective Studies; D012720:Severity of Illness Index; D058616:Synbiotics; D013997:Time Factors; D016896:Treatment Outcome
D005685:Galactans; D005965:Glucuronates; D009844:Oligosaccharides; C570991:xylooligosaccharide; C005653:arabinogalactan