Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution in Children Ages 1-5 Years Presenting to Hospital With Mild or Moderate Dehydration Gastroenteritis: Randomized, Open-label, Controlled Trial

This is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ORS compared with a commercial ORS in children 1 to 5 years of age attending emergency departments with gastroenteritis.

Inclusion Criteria:

• 1 to 5 years of age, inclusive at randomization
• Hospitalized with mild to moderate dehydration due to ongoing diarrhea
• Signed informed consent obtained for child's participation in the study

Exclusion Criteria:

• Severe dehydration and/or use of IV fluids for current hospitalization
• Experiencing bloody diarrhea or diarrhea due to Cholera, Dysentery, persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated with recent antibiotic use
• In the opinion of the Investigator, not suitable for treatment with ORS
• Have any underlying disease or disorder that may, in the opinion of the Investigator, affect the results of the study if they were enrolled (includes, but is not limited to, gastrointestinal disorders such as Crohn's disease or other inflammatory bowel disease or congenital malabsorption disorders)
• Cause of the dehydration is something other than diarrhea
• Known to be allergic to any of the components of the Investigational ORS