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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic | Placebo Comparator | Probiotic product with Sacharomices Boulardii |
|
| probiotic yogurt | Active Comparator | Yogurt with Lactobacilus Rhamnonsus strain spp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic yogurt | Dietary Supplement | Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe E Grandy, MD MSc | Centro Pediatrico Albina Patino | Principal Investigator |
| Richard M Soria, MD | Centro Pediatrico Albina Patino | Study Director |
| Sdenka Jose, MD | Centro Pediatrico Albina Patino | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Pediatrico Albina Patino | Cochabamba | Cochabamba | 0866 | Bolivia |
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| Placebo probiotic | Drug | Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days. |
|
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| five days |
| duration of hospitalization | participants will be followed for the duration of hospital stay, an expected average of 5 days | five days |