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.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis Acute
• Intervention / Treatment: Dietary supplement: Glucose containing Oral Rehydration Solution (ORS); Dietary supplement: Sugar free - amino acid and electrolyte ORS

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Siriraj Hospital
  • Bangkok, Thailand
    • Ramathibodi Hospital
  • Chiang Mai, Thailand
    • Maharaj Nakorn Chiang Mai Hospital
  • Phitsanulok, Thailand
    • Naresuan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Commercial reduced-osmolarity oral rehydration solution (ORS	Dietary supplement: Glucose containing Oral Rehydration Solution (ORS); Oral rehydration solution
Experimental: VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes	Dietary supplement: Sugar free - amino acid and electrolyte ORS; Glucose free oral rehydration solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	Assess change in clinical hydration status from presenting baseline status	every 4 hours up to 24 hours or hospital discharge, whichever occurs first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)	5 point scale, 1(no discomfort) minimum, 5 (severe discomfort) maximum	Baseline
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	kg	Every 4 hours up to 24 h or at hospital discharge, whichever occurs first
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
Frequency episodes of urination		every 4 hours up to 24 hours or hospital discharge, whichever occurs first
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

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): September 20, 2023
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: 5003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No