Acute Gastroenteritis
Conditions
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.
Interventions
DRUGBacillus clausii
Pharmaceutical form:aqueous suspension Route of administration: oral
Pharmaceutical form:vials/sachets for solution Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Mean number of stools per day | Day 1 to Day 5 |
| Effect on consistency of stool | Day 1 to Day 5 |
| Number of vomiting episodes per day | Day 1 to Day 5 |
| 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 |
| Safety outcome: Adverse events collection reported by the parent / legal guardian in diary and checked by the investigator | Day 1 to Day 5 |
Countries
Argentina, Brazil, Colombia, Mexico, Peru
Outcome results
None listed