Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children

Study Overview
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Brief Summary
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Primary Objective: To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children. Secondary Objectives: To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes. To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).

Detailed Description
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The maximum duration of study participation for each patient can be 10 days.

Official Title
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Bacillus Clausii in the Treatment of Acute Community-acquired Diarrhea Among Latin American Children (cadiLAc)

Conditions
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Acute Gastroenteritis

Intervention / Treatment
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* Drug: Bacillus clausii
* Drug: Oral Rehydration Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Infants or children with acute community-acquired diarrhea (≥3 liquid or watery stools occurring in a 24-hour period): with less than 48 hours duration aged between 6 months and 5 years of age whose parents or legal guardians have given their written informed consent with clinical indication for ORT per formula of World Health Organization Exclusion criteria: Infants or children with: presence of blood, pus, or mucus in stools severe dehydration untreatable vomiting antibiotics indication for the treatment of this acute diarrhea; hospitalization expected hospitalization for the next hours due to the poor clinical conditions treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment (the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, milk prior to the study is permitted) previous use (within 48 hours) of kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents indication of any other ORT different from the one prescribed in the study chronic diseases including chronic diarrhea immunodeficiency (acquired or congenital immunodeficiency) other infectious comorbid conditions known hypersensitivity to Bacillus clausii (Enterogermina) or other probiotics parent/legal guardian who, in the opinion of the Investigator, is unable to complete the patient diary or bring the child for the follow-up visit participation in another clinical trial in the last 3 months prior to the start of the study. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enterogermina + Enterolyte<br>2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation | Drug: Bacillus clausii<br>* Pharmaceutical form:aqueous suspension Route of administration: oral<br>* Other names: Enterogermina;Drug: Oral Rehydration Therapy<br>* Pharmaceutical form:vials/sachets for solution Route of administration: oral<br>* Other names: Enterolyte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhea-from the date and time of first intake of investigational product up to date and time of first appearance of a loose stool followed by two consecutive normal stools recorded in the patient diary |  | from Day 1 to Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of stools per day |  | Day 1 to Day 5 | 
| Effect on consistency of stool |  | Day 1 to Day 5 | 
| Number of vomiting episodes per day |  | Day 1 to Day 5 | 
| Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina |  | Day 1 to Day 5 | 
| Parent / Legal guardian's assessment of children's overall general state |  | Day 1 to Day 5 | 
| Safety outcome: Adverse events collection reported by the parent / legal guardian in diary and checked by the investigator |  | Day 1 to Day 5 |