The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
Background: Treatment of acute diarrhea is based on the following various oral rehydration management guidelines. Lately other drugs currently under investigation as antisecretory drugs to shorten the diarrheal episode and can be used safely in children. Objectives: To evaluate the effect of racecadotril in the treatment of children under 5 years of age with acute diarrhea. Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients: One group will receive racecadotril plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of stools by day, weight of stool, nutritional state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
cornstarch powder diluted in distilled water, dosage 2.5 ml per dose
Centro Pediatrico Albina de Patino
Cochabamba, Departamento de Cochabamba, Bolivia
Duration of diarrheal episode
Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days
Time frame: five days
Duration of hospitalization
Participants was followed for the duration of hospitalization, we expected average of 5 days
Time frame: five days
Weight of stool
We expected the weight of the stool will diminish by about 5 days
Time frame: five days
Frequency of stool per day
We expected the frequency of stool will diminish by about 5 days
Time frame: five days
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