SABINA: Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children
Study Details
Study Description
Brief Summary
- 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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To assess the efficacy of the probiotics in improving the frequency and consistency of stools.
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To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.
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To assess the efficacy of the probiotics on the disease severity.
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To assess the safety and tolerability of the studied probiotics.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Saccharomyces boulardii Floratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. |
Biological: Probiotic : Saccharomyces boulardii
Treatment for 5 days
|
| Active Comparator: Bacillus clausii Enterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. |
Biological: Probiotic : Bacillus clausii
Treatment for 5 days
|
Outcome Measures
Primary Outcome Measures
- Time frame in hours up to the time of the last liquid or loose stool as recorded in the stool diary [5 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Children of both gender aged between 6 months and 5 years
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Presenting with acute diarrhea (3 or more loose or liquid stools in a 24-hour period) since at least the last 24h but less than 5 days
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Signed informed consent of the legal representatives obtained before any study procedure
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Parents able to fulfill in the stool diary according to the physician's opinion.
Exclusion Criteria:
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Unable to take medication and fluids by mouth
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More than 50% breastfeeding
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Severe malnutrition, defined by a ratio weight/height at/or below -3SD
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Severe dehydration, defined by a need of IV rehydration
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Chronic underlying disease, including but not limited to severe gastrointestinal disorder, immunocompromised condition or systemic infection
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Use of prohibited treatments
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Contra-indications to the studied probiotics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto Medico | Río Cuarto | Provincia De Cordoba | Argentina | |
| 2 | Instituto Medico | San Juan | Provincia De San Juan | Argentina | |
| 3 | Instituto Medico | San Miguel De Tucumán | Tucuman | Argentina | |
| 4 | Consultario Privado 3 | Caba | Argentina | ||
| 5 | Consultorio Privado 1 | Caba | Argentina | ||
| 6 | Consultorio Privado 2 | Caba | Argentina | ||
| 7 | Consultorio Privado 4 | Caba | Argentina | ||
| 8 | Grupo Pediatrico | Caba | Argentina |
Sponsors and Collaborators
- Biocodex
Investigators
- Study Director: Carine FRANCOIS, Biocodex
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Sb 184