Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

NCT05247879 | Completed

• 1 other identifier: 5003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Gastroenteritis Acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)

  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

  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

Study Arms (2)

Commercial reduced-osmolarity oral rehydration solution (ORS

ACTIVE COMPARATOR

Dietary Supplement: Glucose containing Oral Rehydration Solution (ORS)

VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes

EXPERIMENTAL

Dietary Supplement: Sugar free - amino acid and electrolyte ORS

Interventions

Glucose containing Oral Rehydration Solution (ORS) DIETARY_SUPPLEMENT

Oral rehydration solution

Commercial reduced-osmolarity oral rehydration solution (ORS

Sugar free - amino acid and electrolyte ORS DIETARY_SUPPLEMENT

Glucose free oral rehydration solution

VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mead Johnson Nutrition: lead

Study Sites (4)

Ramathibodi Hospital

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Location

Naresuan University Hospital

Phitsanulok, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 21, 2022
• Study Start: June 30, 2022
• Primary Completion: September 20, 2023
• Study Completion: January 18, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (4)