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

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.