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

Phase 4

Completed

• Conditions: Acute Gastroenteritis
• Interventions: Drug: Bacillus clausii; Drug: Oral Rehydration Therapy

• Registration Number: NCT02169817
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-23
• Study Start: 2014-07
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enterogermina + Enterolyte	Bacillus clausii	2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation
Enterogermina + Enterolyte	Oral Rehydration Therapy	2 vials of Enterogermina per day for 5 days and Enterolyte according to investigator´s recommendation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Effect on consistency of stool	Day 1 to Day 5
Mean number of stools per day	Day 1 to Day 5
Number of vomiting episodes per day	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

Trial Locations

Locations (11)

076003; 🇧🇷 Salvador, Brazil

06; 🇦🇷 San Miguel de Tucuman, Argentina

076002; 🇧🇷 Curitiba, Brazil

076006; 🇧🇷 Porto Alegre, Brazil

076001; 🇧🇷 Sao Paulo, Brazil

04; 🇦🇷 Pilar, Buenos Aires, Argentina

01; 🇦🇷 Mar del Plata, Argentina

170002; 🇨🇴 Armenia, Colombia

484010; 🇲🇽 Mexico city, Mexico

604001; 🇵🇪 Lima, Peru

604003; 🇵🇪 Lima, Peru