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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Racecadotril | Active Comparator | intestinal antisecretory |
|
| cornstach solution | Placebo Comparator | Cornstarch powder diluted in distilled water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Racecadotril | Drug | Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of diarrheal episode | Duration of diarrheal episode, time in which the watery stools will be normalized, an expected average of 5 days | five days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospitalization | Participants was followed for the duration of hospitalization, we expected average of 5 days | five days |
| Weight of stool | We expected the weight of the stool will diminish by about 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Grandy, MD MSc | Centro Pediatrico Albina de Ptino | Study Director |
| Richard Soria, MD | Centro Pediatrico Albina de Patino | Principal Investigator |
| Jackeline Torrez, MD | Centro Pediatrico Albina de Patino | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Pediatrico Albina de Patino | Cochabamba | Cochabamba | Bolivia |
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| ID | Term |
|---|---|
| C049331 | racecadotril |
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| Placebo | Other | cornstarch powder diluted in distilled water, dosage 2.5 ml per dose |
|
| five days |
| Frequency of stool per day | We expected the frequency of stool will diminish by about 5 days | five days |