NCT02169817

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 629 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

Conditions

• Acute Gastroenteritis

Interventions

Type	Name	Description
DRUG	Bacillus clausii	Pharmaceutical form:aqueous suspension Route of administration: oral
DRUG	Oral Rehydration Therapy	Pharmaceutical form:vials/sachets for solution Route of administration: oral

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-06-23
• Last updated: 2016-01-21

Locations

11 sites across 5 countries: Argentina, Brazil, Colombia, Mexico, Peru