Use of Probiotic Yogurt in the Treatment of Acute 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 probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products.

Detailed Description
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Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, considering the advances in treatment, Lactobacillus Rahmnosus has being well described as a probiotic who reduces the number of days of hospitalization and also de the severity. Objectives: To evaluate the effect of the probiotic yogurt in the treatment of children who are between 10 months and 3 years old with acute non-dysenteric diarrhea. Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive Lactobacillus Rahmnosus in a yogurt presentation and the other one will receive Sacharomyces boulardii in a lyophilized form ; the parameters of evaluation are going to be the number of diarrhea stools by day, number of vomiting episodes, hours with fever, nutritional and immunization state.

Official Title
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Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial

Conditions
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Acute Diarrhea, Acute Gastroenteritis

Intervention / Treatment
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* Dietary Supplement: Probiotic yogurt
* Drug: Placebo probiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All acute diarrhea Exclusion Criteria: Severe malnourishment Severe dehydration Systemic infections

Ages Eligible for Study
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Minimum Age: 10 Months
Maximum Age: 36 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: probiotic<br>Probiotic product with Sacharomices Boulardii | Drug: Placebo probiotic<br>* Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.<br>* Other names: Florestor;|
| Active Comparator: probiotic yogurt<br>Yogurt with Lactobacilus Rhamnonsus strain spp | Dietary Supplement: Probiotic yogurt<br>* Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhea | participants will be followed for the duration of hospital stay, an expected average of 5 days | five days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of fever | participants will be followed for the duration of hospital stay, an expected average of 5 days | five days | 
| duration of vomiting | participants will be followed for the duration of hospital stay, an expected average of 5 days | five days | 
| duration of hospitalization | participants will be followed for the duration of hospital stay, an expected average of 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, probiotics, children