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

Acute Gastroenteritis Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial Description

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

• NCT number: NCT02169817
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 4
• Start date: July 2014
• Completion date: January 2016