Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

Mead Johnson Nutrition

Status

Completed

Conditions

Gastroenteritis Acute

Treatments

Dietary Supplement: Glucose containing Oral Rehydration Solution (ORS)

Dietary Supplement: Sugar free - amino acid and electrolyte ORS

Study type

Interventional

Funder types

Industry

Identifiers

NCT05247879

5003

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

1 to 5 years old

Volunteers

No Healthy Volunteers

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