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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Acute Gastroenteritis

Treatments

Drug: Bacillus clausii

Drug: Oral Rehydration Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT02169817

ENTERR06929

U1111-1149-1704 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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

Enrollment

629 patients

Sex

All

Ages

6 months to 5 years old

Volunteers

No Healthy Volunteers

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.