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

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.