Gastroenteritis Acute
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTGlucose containing Oral Rehydration Solution (ORS)
Oral rehydration solution
DIETARY_SUPPLEMENTSugar free - amino acid and electrolyte ORS
Glucose free oral rehydration solution
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically assessed adequate rehydration based on clinical judgement of change in or absence of presenting symptoms from baseline (i.e. heart rate, urine output, etc.) | every 4 hours up to 24 hours or hospital discharge, whichever occurs first | Assess change in clinical hydration status from presenting baseline status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study ORS intake (units) | Every 4 hours up to 24 hours or hospital discharge, whichever occurs first | — |
| Use of IV fluids | up to 24 hours or hospital discharge, whichever occurs first | — |
| Weight | Every 4 hours up to 24 h or at hospital discharge, whichever occurs first | kg |
| Participant comfort questionaire | baseline and 24 hours or hospital discharge, whichever occurs first | — |
| Parent satisfaction questionnaire | baseline and 24 hours or hospital discharge, whichever occurs first | — |
| Frequency of vomiting | every 4 hours up to 24 hours or hospital discharge, whichever occurs first | — |
| Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.) | Baseline | 5 point scale, 1(no discomfort) minimum, 5 (severe discomfort) maximum |
| Frequency of liquid/watery stool | every 4 hours up to 24 hours or hospital discharge, whichever occurs first | — |
| Time to resolution of liquid/water stool | up to 24 hours or hospital discharge, whichever comes first | — |
| Stool for bacterial pathogen culture and viral antigens | up to 24 hours or hospital discharge, whichever comes first | — |
| Time ready for discharge | At discharge or 48 hours whichever occurs first | — |
| Medically confirmed adverse events collected throughout the study period | 0 hours through 7 days post discharge | — |
| Record patient use of antibiotics during hospitalization | up to 24 hours or hospital discharge, whichever comes first | — |
| Frequency episodes of urination | every 4 hours up to 24 hours or hospital discharge, whichever occurs first | — |
Countries
Thailand
Outcome results
None listed