Use of racecadotril as outpatient treatment for acute gastroenteritis: a prospective, randomized, parallel study

J Pediatr. 2009 Jul;155(1):62-7. doi: 10.1016/j.jpeds.2009.01.064. Epub 2009 Apr 24.


Objective: To compare the efficacy of therapy with racecadotril plus oral rehydration versus oral rehydration alone in children with gastroenteritis in an outpatient setting care.

Study design: Prospective, randomized, open and parallel study performed in a Pediatric Emergency Service of a tertiary care hospital. The study included 189 patients, ages 3 to 36 months, with acute gastroenteritis: 94 were administered an oral rehydration solution (OR), 94 received oral rehydration solution plus racecadotril (OR + R). The principal variable studied was the number of bowel movements in 48 hours after initiating treatment.

Results: The groups were comparable clinically and epidemiologically at enrollment. No significant differences were found in the number of bowel movements between the 2 groups 48 hours after initiating treatment (4.1 +/- 2.7 bowel movements in the OR group vs 3.8 +/- 2.4 bowel movements in the OR + R group). No differences were found in the average duration of gastroenteritis (4.7 +/- 2.2 days in the OR group, 4.0 +/- 2.1 days in the OR + R group; P = .15). The incidence of adverse events was similar in both groups (19 patients [20.2%] in the OR group, 18 patients [19.1%] in the OR + R group).

Conclusions: In our study group, the use of racecadotril did not improve the symptoms of diarrhea compared with standard rehydration therapy.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Ambulatory Care*
  • Antidiarrheals / therapeutic use*
  • Dehydration / etiology
  • Dehydration / therapy
  • Diarrhea / drug therapy
  • Drug Therapy, Combination
  • Emergency Service, Hospital
  • Female
  • Gastroenteritis / drug therapy*
  • Humans
  • Infant
  • Male
  • Prospective Studies
  • Rehydration Solutions / therapeutic use
  • Thiorphan / analogs & derivatives*
  • Thiorphan / therapeutic use


  • Antidiarrheals
  • Rehydration Solutions
  • racecadotril
  • Thiorphan