Clinical trial NCT02169817: Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children
Official title: Bacillus Clausii in the Treatment of Acute Community-acquired Diarrhea Among Latin American Children (cadiLAc)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Gastroenteritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 629
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: from Day 1 to Day 5
Secondary outcomes:
measure: Mean number of stools per day
timeFrame: Day 1 to Day 5
measure: Effect on consistency of stool
timeFrame: Day 1 to Day 5
measure: Number of vomiting episodes per day
timeFrame: Day 1 to Day 5
measure: Parent / Legal guardian's assessment of children's overall acceptance of Enterogermina
timeFrame: Day 1 to Day 5
measure: Parent / Legal guardian's assessment of children's overall general state
timeFrame: Day 1 to Day 5
measure: Safety outcome: Adverse events collection reported by the parent / legal guardian in diary and checked by the investigator
timeFrame: Day 1 to Day 5
Other outcomes:
Locations:
city: Pilar
country: Argentina
facility: 04
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: 01
city: San Miguel de Tucuman
country: Argentina
facility: 06
city: Curitiba
country: Brazil
facility: 076002
city: Porto Alegre
country: Brazil
facility: 076006
city: Salvador
country: Brazil
facility: 076003
city: Sao Paulo
country: Brazil
facility: 076001
city: Armenia
country: Colombia
facility: 170002
city: Mexico city
country: Mexico
facility: 484010
city: Lima
country: Peru
facility: 604001
city: Lima
country: Peru
facility: 604003
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: