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Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

CompletedNA

Sponsor: Mead Johnson Nutrition

Conditions: Gastroenteritis Acute

Interventions: Glucose containing Oral Rehydration Solution (ORS), Sugar free - amino acid and electrolyte ORS

Countries: Thailand

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.

Eligibility overview

Sex: ALL

Age: 1 Year to 5 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (4)

Bangkok, Thailand
Bangkok, Thailand
Chiang Mai, Thailand
Phitsanulok, Thailand