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

• Published in: The Journal of pediatrics Vol. 158; no. 2; pp. 288 - 292.e1
• Main Authors: Passariello, Annalisa, MD, PhD, Terrin, Gianluca, MD, PhD, De Marco, Giulio, MD, PhD, Cecere, Gaetano, MD, Ruotolo, Serena, MD, Marino, Antonio, MD, Cosenza, Linda, MD, Tardi, Maria, MD, Nocerino, Rita, NR, Berni Canani, Roberto, MD, PhD
• Format: Journal Article
• Language: English
• Published: Maryland Heights, MO Elsevier Inc 01.02.2011; Mosby, Inc; Elsevier
• Subjects: Acute Disease; Biological and medical sciences; Child, Preschool; childhood; children; Confidence Intervals; diarrhea; Diarrhea - diagnosis; Diarrhea - mortality; Diarrhea - therapy; Diarrhea, Infantile - diagnosis; Diarrhea, Infantile - mortality; Diarrhea, Infantile - therapy; drugs; Female; Fluid Therapy - methods; Follow-Up Studies; Gastroenterology. Liver. Pancreas. Abdomen; General aspects; Humans; Hypotonic Solutions - therapeutic use; Infant; Italy; Kaplan-Meier Estimate; Male; Medical sciences; Odds Ratio; oral rehydration; Other diseases. Semiology; parents; patients; Pediatrics; Prebiotics; Prospective Studies; randomized clinical trials; Reference Values; Rehydration Solutions - therapeutic use; Risk Assessment; Severity of Illness Index; Single-Blind Method; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Survival Rate; Treatment Outcome; zinc; Zinc - therapeutic use; Italy; ORS; FOS; Oral rehydration solution; Fructooligosaccharides; Human; Pediatrics; Hypotonic solution; Acute; Treatment efficiency; Oral administration; Diarrhea; Controlled therapeutic trial; Randomized controlled trial; Zinc; Randomization; Treatment; Rehydration; Digestive diseases; Intestinal disease; Clinical trial; Child; Prebiotic
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/j.jpeds.2010.07.055

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.