Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

• Sponsor: Mead Johnson Nutrition (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05247879
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 6.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroenteritis Acute	Dietary Supplement: Glucose containing Oral Rehydration Solution (ORS); Dietary Supplement: Sugar free - amino acid and electrolyte ORS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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
• Anticipated Study Start Date: May 2, 2022
• Anticipated Primary Completion Date: Oct 17, 2022
• Anticipated Study Completion Date: Nov 17, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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.) [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

1. 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

2. Study ORS intake (units) [Every 4 hours up to 24 hours or hospital discharge, whichever occurs first]

3. Use of IV fluids [up to 24 hours or hospital discharge, whichever occurs first]

4. Weight [Every 4 hours up to 24 h or at hospital discharge, whichever occurs first]

   kg

5. Participant comfort questionaire [baseline and 24 hours or hospital discharge, whichever occurs first]

6. Parent satisfaction questionnaire [baseline and 24 hours or hospital discharge, whichever occurs first]

7. Frequency of vomiting [every 4 hours up to 24 hours or hospital discharge, whichever occurs first]

8. Frequency episodes of urination [every 4 hours up to 24 hours or hospital discharge, whichever occurs first]

9. Frequency of liquid/watery stool [every 4 hours up to 24 hours or hospital discharge, whichever occurs first]

10. Time to resolution of liquid/water stool [up to 24 hours or hospital discharge, whichever comes first]

11. Stool for bacterial pathogen culture and viral antigens [up to 24 hours or hospital discharge, whichever comes first]

12. Time ready for discharge [At discharge or 48 hours whichever occurs first]

13. Medically confirmed adverse events collected throughout the study period [0 hours through 7 days post discharge]

14. Record patient use of antibiotics during hospitalization [up to 24 hours or hospital discharge, whichever comes first]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 5 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mead Johnson Nutrition

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mead Johnson Nutrition
• ClinicalTrials.gov Identifier: NCT05247879
• Other Study ID Numbers: 5003
• First Posted: Feb 21, 2022
• Last Update Posted: Feb 21, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroenteritis

Study Results

No Results Posted as of Feb 21, 2022