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

Acute Gastroenteritis Clinical Trial

— cadiLAc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169817
• Other study ID #: ENTERR06929
• Secondary ID: U1111-1149-1704
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2014
• Last updated: January 20, 2016
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 629
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

Drug:
• Bacillus clausii
Pharmaceutical form:aqueous suspension Route of administration: oral
• Oral Rehydration Therapy
Pharmaceutical form:vials/sachets for solution Route of administration: oral

Locations

Country	Name	City	State
Argentina	01	Mar del Plata
Argentina	04	Pilar	Buenos Aires
Argentina	06	San Miguel de Tucuman
Brazil	076002	Curitiba
Brazil	076006	Porto Alegre
Brazil	076003	Salvador
Brazil	076001	Sao Paulo
Colombia	170002	Armenia
Mexico	484010	Mexico city
Peru	604001	Lima
Peru	604003	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Argentina,  Brazil,  Colombia,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean number of stools per day		Day 1 to Day 5	No
Secondary	Effect on consistency of stool		Day 1 to Day 5	No
Secondary	Number of vomiting episodes per day		Day 1 to Day 5	No
Secondary	Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina		Day 1 to Day 5	No
Secondary	Parent / Legal guardian's assessment of children's overall general state		Day 1 to Day 5	No
Secondary	Safety outcome: Adverse events collection reported by the parent / legal guardian in diary and checked by the investigator		Day 1 to Day 5	Yes