title: Racecadotril in the Management of Rotavirus and Non-rotavirus Diarrhea in Under-five Children: Two Randomized, Double-blind, Placebo-controlled Trials.
abstract: OBJECTIVE
  To study the effect of racecadotril on reduction in the duration of acute rotavirus and non-rotavirus diarrhea.
  
  
  METHODS
  Two randomized double-blind placebo-controlled trials.
  
  
  METHODS
  Community-based trial in an urban area in Vellore, hospital-based trial at a secondary hospital in Vellore.
  
  
  METHODS
  199 and 130 3-59 month old children in the community- and hospital-based trials, respectively.
  
  
  METHODS
  Racecadotril (1.5 mg/kg/dose, thrice a day for three days) or placebo were given to manage acute diarrhea in both trials.
  
  
  METHODS
  Median duration of diarrhea.
  
  
  RESULTS
  Among 124 children completing the hospital trial, the median duration of diarrhea was 25 h in both arms (P=0.5); median total stool weight was 74 g/kg and 53.5 g/kg in racecadotril group and placebo group, respectively (P=0.4); and average fluid intake per day was 3.6 mL/kg/h and 3mL/kg/h in racecadotril and placebo arms, respectively (P=0.3). Among rotavirus-positive children, median duration of diarrhea was 26.9 h and 30.2 h in racecadotril and placebo arms, respectively (P=0.7). In the community, 196 completed the trial, the median duration of diarrhea was 2 days for both arms (P=0.8) and rotavirus positive children had similar outcomes with median diarrheal duration of 3 d in both arms (P=0.4).
  
  
  CONCLUSIONS
  Treatment with racecadotril did not reduce diarrheal duration, stool volume or the requirement for fluid replacement in children with acute gastroenteritis, both with and without rotavirus infection.
authors: Departments of Gastrointestinal Sciences, Christian Medical College, Vellore, India; *Service des Urgences Pediatriques, Hopital d enfants Armand Trousseau, Assistance Publique-Hopitaux de Paris, Paris, France; #Division of Molecular Virology, Department of Clinical and Experimental Medicine, Medical Faculty, Linko ping University, Linko ping, Sweden; and $Community Health, Christian Medical College, Vellore, India. Correspondence to: Dr. Gagandeep Kang, Professor and Head, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. gkang@cmcvellore.ac.in.
authors: Gagandeep
authors: G
authors: Kang
authors: Sowmyanarayanan V
authors: SV
authors: Thuppal
authors: Rajan
authors: R
authors: Srinivasan
authors: Rajiv
authors: R
authors: Sarkar
authors: Beula
authors: B
authors: Subashini
authors: Srinivasan
authors: S
authors: Venugopal
authors: Kulandaipalayam
authors: K
authors: Sindhu
authors: Dhivya
authors: D
authors: Anbu
authors: Nathalie
authors: N
authors: Parez
authors: Lennart
authors: L
authors: Svensson
authors: Anuradha
authors: A
authors: Bose
mesh_terms: D000930:Antidiarrheals / Q000627:therapeutic use*; D002675:Child, Preschool; D003967:Diarrhea / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012400:Rotavirus Infections / Q000188:drug therapy*; D015244:Thiorphan / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000930:Antidiarrheals; C049331:racecadotril; D015244:Thiorphan