NCT05247879

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mead Johnson Nutrition · Industry
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Glucose containing Oral Rehydration Solution (ORS)	Oral rehydration solution
DIETARY_SUPPLEMENT	Sugar free - amino acid and electrolyte ORS	Glucose free oral rehydration solution

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-09-20
• Completion: 2024-01-18
• First posted: 2022-02-21
• Last updated: 2024-03-25

Locations

4 sites across 1 country: Thailand