ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children

Study Overview
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Brief Summary
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Primary: To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children Secondary: To evaluate the safety of Enterogermina® in acute diarrhea in Indian children

Official Title
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Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Days With the Treatment of Acute Diarrhea in Children.

Conditions
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Gastroenteritis

Intervention / Treatment
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* Drug: Bacillus Clausii
* Other: Oral rehydration therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration Exclusion Criteria: History of presence of blood, pus, or mucus in stools Severe dehydration (World Health Organization criteria) Severely malnourished patients Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc) Known hypersensitivity to Bacillus clausii or other probiotics. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii) | Drug: Bacillus Clausii<br>* For 5 days<br>|
| Placebo Comparator: 2<br>Administration of Oral rehydration therapy | Other: Oral rehydration therapy<br>* For 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in duration of diarrhea |  | Throughout the treatment period | 
| Incidence of adverse events |  | Throughout the study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of stools per day |  | Throughout the treatment period | 
| Effect on consistency of stools |  | Throughtout the treatment period | 
| Vomiting episodes per day |  | Throughout the treatment period | 
| Requirement of unscheduled intravenous transfusion |  | Throughout the study period | 
| Need for hospitalization |  | Throughout the treatment period |