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Efficacy and tolerability of racecadotril in acute diarrhea in children

J P Cézard1, J F Duhamel, M Meyer

  • 1Pediatric Gastroenterology Unit, Paris, France. jean-pierre.cezard@rdb.ap-hop-paris.fr

Gastroenterology
|March 7, 2001
PubMed

Insights

Racecadotril significantly reduces stool output in infants with acute diarrhea when used with oral rehydration therapy. This study confirms its efficacy and good tolerability as a treatment for severe diarrhea in children.

Area of Science:

  • Pediatric Gastroenterology
  • Pharmacology
  • Infectious Diseases

Background:

  • Oral rehydration therapy (ORT) is the WHO-recommended treatment for acute diarrhea in children.
  • Existing antisecretory drugs have side effects, limiting their use.
  • Racecadotril is an effective antisecretory drug for adult acute diarrhea.

Purpose of the Study:

  • To evaluate the efficacy and tolerability of racecadotril as an adjuvant to ORT in infants with acute diarrhea.
  • To compare racecadotril with placebo in pediatric patients.

Main Methods:

  • A randomized controlled trial involving 172 infants (3 months to 4 years) with acute diarrhea.
  • Racecadotril (1.5 mg/kg orally 3 times daily) or placebo was administered alongside ORT.
  • Efficacy measured by stool output reduction; tolerability assessed.

Main Results:

  • Racecadotril significantly reduced stool output (grams per hour) compared to placebo within 48 hours.
  • Significant differences in stool output were observed after 24 hours.
  • No difference in efficacy based on rotavirus status; good tolerability in both groups.

Conclusions:

  • Racecadotril is an effective and well-tolerated adjuvant therapy for severe acute diarrhea in infants and children.
  • It can reduce stool output by up to 50% when combined with ORT.
  • This supports racecadotril's use in pediatric diarrhea management.
Abstract

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