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Primary Objective:
o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saccharomyces boulardii | Active Comparator | Floratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. |
|
| Bacillus clausii | Active Comparator | Enterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic : Saccharomyces boulardii | Biological | Treatment for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary | Time frame in hours up to the time of the last liquid or loose stoll (defined as type 6 or 7 on Bristol Stool Scale) followed by the first 24-hour period with stool consistency improvement (no liquid or loose stool), i.e. cessation of diarrhea as recorded by the parents in the stool diary. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carine FRANCOIS | Biocodex | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Medico | Río Cuarto | Córdoba Province | Argentina | |||
| Instituto Medico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36086703 | Derived | Altcheh J, Carosella MV, Ceballos A, D'Andrea U, Jofre SM, Marotta C, Mugeri D, Sabbaj L, Soto A, Josse C, Montestruc F, McFarland LV. Randomized, direct comparison study of Saccharomyces boulardii CNCM I-745 versus multi-strained Bacillus clausii probiotics for the treatment of pediatric acute gastroenteritis. Medicine (Baltimore). 2022 Sep 9;101(36):e30500. doi: 10.1097/MD.0000000000030500. | |
| 33295643 |
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Allocation-blinded study
| Probiotic : Bacillus clausii |
| Biological |
Treatment for 5 days |
|
| San Juan |
| San Juan Province |
| Argentina |
| Instituto Medico | San Miguel de Tucumán | Tucumán Province | Argentina |
| Consultario Privado 3 | CABA | Argentina |
| Consultorio Privado 1 | CABA | Argentina |
| Consultorio Privado 2 | CABA | Argentina |
| Consultorio Privado 4 | CABA | Argentina |
| Grupo Pediatrico | CABA | Argentina |
| Derived |
| Collinson S, Deans A, Padua-Zamora A, Gregorio GV, Li C, Dans LF, Allen SJ. Probiotics for treating acute infectious diarrhoea. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD003048. doi: 10.1002/14651858.CD003048.pub4. |