Efficacy and tolerability of racecadotril in acute diarrhea in children

Gastroenterology. 2001 Mar;120(4):799-805. doi: 10.1053/gast.2001.22544.


Background & aims: Oral rehydration therapy is the only treatment recommended by the World Health Organization in acute diarrhea in children. Antisecretory drugs available could not be used because of their side effects, except for racecadotril, which is efficient in acute diarrhea in adults.

Methods: The efficacy and tolerability of racecadotril (1.5 mg/kg administered orally 3 times daily) as adjuvant therapy to oral rehydration were compared with those of placebo in 172 infants aged 3 months to 4 years (mean age, 12.8 months) who had acute diarrhea. The treatment groups were comparable in terms of age, duration of diarrhea, number of stools, and causative microorganism at inclusion.

Results: During the first 48 hours of treatment, patients receiving racecadotril had a significantly lower stool output (grams per hour) than those receiving placebo. The 95% confidence interval was 43%-88% for the full data set (n = 166; P = 0.009) and 33%-75% for the per-protocol population (n = 116; P = 0.001). There was no difference between treatments depending on rotavirus status. Significant differences between treatment groups were also found after 24 hours of treatment: full data set (n = 167; P = 0.026) and per-protocol population (n = 121; P = 0.015). Tolerability was good in both groups of patients.

Conclusions: This study demonstrates the efficacy (up to 50% reduction in stool output) and tolerability of racecadotril as adjuvant therapy to oral rehydration solution in the treatment of severe diarrhea in infants and children.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Antidiarrheals / adverse effects
  • Antidiarrheals / therapeutic use*
  • Child, Preschool
  • Defecation / drug effects
  • Diarrhea / drug therapy*
  • Diarrhea / physiopathology
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Male
  • Thiorphan / adverse effects
  • Thiorphan / analogs & derivatives*
  • Thiorphan / therapeutic use*
  • Time Factors


  • Antidiarrheals
  • racecadotril
  • Thiorphan