title: Acceptability and efficacy of a gel hypotonic oral rehydration solution in children with acute gastroenteritis.
abstract: OBJECTIVE
  Oral rehydration solution remains the mainstay of acute gastroenteritis therapy. The aim of this study was to investigate the acceptability of a new zinc-containing hypotonic super-oral rehydration solution (ORS) in a gel formulation and its efficacy in reducing the duration and severity of diarrhea in children.
  
  
  METHODS
  This was a randomized-controlled trial of children (5-36 months of age) observed for diarrhea lasting less than 24 h. Children were randomized to receive standard hypotonic ORS (group 1) or a gel hypotonic super-ORS containing zinc (group 2). The main study outcome was ORS intake in the first 24 h. ORS intake at 4 h, rate of diarrhea resolution at 72 h of treatment, total duration and severity of diarrhea, hospitalization, and adverse effects were also evaluated.
  
  
  RESULTS
  Eighty-three children were enrolled (group 1: 40; group 2: 43). The amount of ORS consumed at 24 h was significantly higher in group 2 than in group 1. A similar result was observed at 4 h. The number of children who refused ORS (<10 ml/kg/day) was lower in group 2 versus group 1 (P=0.001). The number of children presenting diarrhea after 72 h of treatment was lower in group 2 versus group 1 (P=0.028). Also, the mean duration of diarrhea was shorter in group 2 than in group 1 (P=0.001). The hypotonic super-ORS containing zinc in a gel formulation had a positive effect on the severity of diarrhea. No patient required hospitalization. No adverse events were observed in either of the two study groups.
  
  
  CONCLUSIONS
  The new zinc-containing hypotonic super-ORS in a gel formulation is effective in the management of childhood acute gastroenteritis.
authors.affiliation: aNeonatology Unit, AORN dei Colli - V. Monaldi Hospital bDepartment of Translational Medical Science - Pediatric Section cEuropean Laboratory for the Investigation of Food Induced Diseases, University of Naples 'Federico II', Naples dDepartment of Gynaecology-Obstetrics and Perinatal Medicine University of Rome 'La Sapienza', Rome, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Passariello
authors.forename: Rita
authors.initials: R
authors.lastname: Nocerino
authors.forename: Gianluca
authors.initials: G
authors.lastname: Terrin
authors.forename: Gaetano
authors.initials: G
authors.lastname: Cecere
authors.forename: Giulio
authors.initials: G
authors.lastname: De Marco
authors.forename: Maria
authors.initials: M
authors.lastname: Micillo
authors.forename: Vincenza
authors.initials: V
authors.lastname: Pezzella
authors.forename: Linda
authors.initials: L
authors.lastname: Cosenza
authors.forename: Monica
authors.initials: M
authors.lastname: Malamisura
authors.forename: Ylenia
authors.initials: Y
authors.lastname: Maddalena
authors.forename: Roberto Berni
authors.initials: RB
authors.lastname: Canani
mesh_terms: D000208:Acute Disease; D002675:Child, Preschool; D003967:Diarrhea / Q000209:etiology; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D005759:Gastroenteritis / Q000150:complications / Q000628:therapy*; D005782:Gels; D006801:Humans; D007038:Hypotonic Solutions; D007223:Infant; D008297:Male; D011446:Prospective Studies; D015532:Rehydration Solutions / Q000008:administration & dosage / Q000627:therapeutic use*; D013997:Time Factors; D016312:Treatment Refusal; D015032:Zinc / Q000627:therapeutic use*
chemical_list: D005782:Gels; D007038:Hypotonic Solutions; D015532:Rehydration Solutions; D015032:Zinc