Racecadotril in the Management of Rotavirus and Non-rotavirus Diarrhea in Under-five Children: Two Randomized, Double-blind, Placebo-controlled Trials.

OBJECTIVE

To study the effect of racecadotril on reduction in the duration of acute rotavirus and non-rotavirus diarrhea.

DESIGN

Two randomized double-blind placebo-controlled trials.

SETTING

Community-based trial in an urban area in Vellore, hospital-based trial at a secondary hospital in Vellore.

PARTICIPANTS

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.

MAIN OUTCOME MEASURE

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.