Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
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).