Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

Study Overview
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Brief Summary
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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: To assess the efficacy of the probiotics in improving the frequency and consistency of stools. To assess the efficacy of the probiotics in avoiding recurrence of diarrhea. To assess the efficacy of the probiotics on the disease severity. To assess the safety and tolerability of the studied probiotics.

Official Title
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Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

Conditions
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Acute Gastroenteritis

Intervention / Treatment
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* Biological: Probiotic : Saccharomyces boulardii
* Biological: Probiotic : Bacillus clausii


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children of both gender aged between 6 months and 5 years 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 Signed informed consent of the legal representatives obtained before any study procedure Parents able to fulfill in the stool diary according to the physician's opinion. Exclusion Criteria: Unable to take medication and fluids by mouth More than 50% breastfeeding Severe malnutrition, defined by a ratio weight/height at/or below -3SD Severe dehydration, defined by a need of IV rehydration Chronic underlying disease, including but not limited to severe gastrointestinal disorder, immunocompromised condition or systemic infection Use of prohibited treatments Contra-indications to the studied probiotics

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saccharomyces boulardii<br>Floratil, 250 mg sachets, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. | Biological: Probiotic : Saccharomyces boulardii<br>* Treatment for 5 days<br>|
| Active Comparator: Bacillus clausii<br>Enterogermina, 5 ml vials, twice daily (1 in the morning and 1 in the evening) during 5 consecutive days. | Biological: Probiotic : Bacillus clausii<br>* Treatment for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |