Efficacy of a new hypotonic oral rehydration solution containing zinc and prebiotics in the treatment of childhood acute diarrhea: a randomized controlled trial.
OBJECTIVE
To evaluate the efficacy of a hypotonic oral rehydration solution (ORS) containing zinc and prebiotics for treatment of acute diarrhea in children.


METHODS
We conducted a single-blind, prospective, controlled trial including children (age range, 3-36 months) with acute diarrhea randomly assigned to standard hypotonic ORS (group 1) or to new hypotonic ORS containing zinc and prebiotics (group 2). The main outcome was the rate of resolution of diarrhea at 72 hours.


RESULTS
A total of 60 children in group 1 (34 male; mean age, 18.58 months; 95% CI, 15.5-21.6) and 59 in group 2 (36 male; mean age, 19.26 months; 95% CI, 15.9-22.6) completed the study protocol. The rate of diarrhea resolution at 72 hours was higher in group 2 (50% versus 72.9%, P = .010). Total ORS intake in the first 24 hours was higher in group 2 (50 mL/kg; 95% CI, 41-59 versus 22 mL/kg; 95% CI, 17-29; P < .001). The mean number of missed working days by the parents of children in group 2 was lower (0.39; 95% CI, 0.08-0.70 versus 1.45; 95% CI 1.02-1.88; P < .001). Fewer patients in group 2 needed adjunctive drugs for the treatment of diarrhea 6/59 versus 19/60, P = .004. No adverse events were observed in either of the two groups.


CONCLUSIONS
The addition of zinc and prebiotics to ORS limits diarrhea duration in children.
Passariello
Annalisa
A
Department of Pediatrics, University of Naples Federico II, Naples, Italy.
Terrin
Gianluca
G
De Marco
Giulio
G
Cecere
Gaetano
G
Ruotolo
Serena
S
Marino
Antonio
A
Cosenza
Linda
L
Tardi
Maria
M
Nocerino
Rita
R
Berni Canani
Roberto
R
D000208:Acute Disease; D002675:Child, Preschool; D016001:Confidence Intervals; D003967:Diarrhea / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003968:Diarrhea, Infantile / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D005500:Follow-Up Studies; D006801:Humans; D007038:Hypotonic Solutions / Q000627:therapeutic use; D007223:Infant; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D016017:Odds Ratio; D056692:Prebiotics; D011446:Prospective Studies; D012016:Reference Values; D015532:Rehydration Solutions / Q000627:therapeutic use*; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D015996:Survival Rate; D016896:Treatment Outcome; D015032:Zinc / Q000627:therapeutic use*
D007038:Hypotonic Solutions; D056692:Prebiotics; D015532:Rehydration Solutions; D015032:Zinc