Elsevier

The Journal of Pediatrics

Volume 158, Issue 2, February 2011, Pages 288-292.e1
The Journal of Pediatrics

Original Article
Efficacy of a New Hypotonic Oral Rehydration Solution Containing Zinc and Prebiotics in the Treatment of Childhood Acute Diarrhea: A Randomized Controlled Trial

https://doi.org/10.1016/j.jpeds.2010.07.055Get rights and content

Objective

To evaluate the efficacy of a hypotonic oral rehydration solution (ORS) containing zinc and prebiotics for treatment of acute diarrhea in children.

Study design

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.

Conclusion

The addition of zinc and prebiotics to ORS limits diarrhea duration in children.

Section snippets

Methods

We performed a prospective, randomized, single-blind controlled trial in collaboration with family pediatricians, who care for children up to 14 years of age in the Italian Public Health System. The study protocol was illustrated and discussed during 3 meetings. The study protocol was reviewed and approved by the ethics committee of the University Federico II of Naples.

From November 2007 to March 2008, all children aged 3 to 36 months consecutively observed in pediatrician offices with diarrhea

Results

Figure 1 (available at www.jpeds.com) shows the flow of children through the study; 65 children in each group were allocated to intervention. The baseline, demographic, and clinical characteristics were similar in the 2 groups (Table II). Resolution of diarrhea at 72 hours was observed in 30 of 60 children in group 1 (50.0%) and in 43 of 59 children in group 2 (72.9%, P = .010; Figure 2). The number of daily outputs was significantly reduced in group 2 compared with group 1 at 24 hours (4.5;

Discussion

In this trial, we investigated the therapeutic efficacy of a new commercially available hypotonic ORS containing zinc and prebiotics in the treatment of acute diarrhea in children. The positive clinical effect exerted by this new ORS on diarrhea could be related to a synergistic effect between prebiotics and zinc. Prebiotics have been proposed for the prevention and treatment of acute diarrhea, but efficacy data of FOS and xilooligosaccharides in the treatment of acute diarrhea are still scant

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    The authors declare no conflicts of interest.

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