Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution
Not Applicable
Completed
- Conditions
- Gastroenteritis Acute
- Interventions
- Dietary Supplement: Glucose containing Oral Rehydration Solution (ORS)Dietary Supplement: Sugar free - amino acid and electrolyte ORS
- Registration Number
- NCT05247879
- Lead Sponsor
- Mead Johnson Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Commercial reduced-osmolarity oral rehydration solution (ORS Glucose containing Oral Rehydration Solution (ORS) - VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes Sugar free - amino acid and electrolyte ORS -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time to resolution of liquid/water stool up to 24 hours or hospital discharge, whichever comes first 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 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 Record patient use of antibiotics during hospitalization up to 24 hours or hospital discharge, whichever comes first Participant comfort questionaire baseline and 24 hours or hospital discharge, whichever occurs first Frequency episodes of urination every 4 hours up to 24 hours or hospital discharge, whichever occurs first Time ready for discharge At discharge or 48 hours whichever occurs first Frequency of liquid/watery stool every 4 hours up to 24 hours or hospital discharge, whichever occurs first Medically confirmed adverse events collected throughout the study period 0 hours through 7 days post discharge Weight Every 4 hours up to 24 h or at hospital discharge, whichever occurs first kg
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
Stool for bacterial pathogen culture and viral antigens up to 24 hours or hospital discharge, whichever comes first
Trial Locations
- Locations (4)
Siriraj Hospital
🇹🇭Bangkok, Thailand
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Chiang Mai, Thailand
Naresuan University Hospital
🇹🇭Phitsanulok, Thailand