Efficacy of Racecadotril in Acute Watery Diarrhea in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children

Conditions
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Acute Diarrhea, Acute Gastroenteritis

Intervention / Treatment
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* Drug: Racecadotril
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute watery diarrhea Exclusion Criteria: Severe malnourishment Severe dehydration Systemic infections Coinfections

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Racecadotril<br>intestinal antisecretory | Drug: Racecadotril<br>* Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day<br>* Other names: Hidrasec;|
| Placebo Comparator: cornstach solution<br>Cornstarch powder diluted in distilled water | Other: Placebo<br>* cornstarch powder diluted in distilled water, dosage 2.5 ml per dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | five days | 
| Frequency of stool per day | We expected the frequency of stool will diminish by about 5 days | five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute diarrhea, Racecadotril, children