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Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

Primary Purpose

Gastroenteritis Acute

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Glucose containing Oral Rehydration Solution (ORS)
Sugar free - amino acid and electrolyte ORS
Sponsored by
Mead Johnson Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastroenteritis Acute

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ramathibodi HospitalRecruiting
  • Siriraj HospitalRecruiting
  • Maharaj Nakorn Chiang Mai HospitalRecruiting
  • Naresuan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Commercial reduced-osmolarity oral rehydration solution (ORS

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Study ORS intake (units)
Use of IV fluids
Weight
kg
Participant comfort questionaire
Parent satisfaction questionnaire
Frequency of vomiting
Frequency episodes of urination
Frequency of liquid/watery stool
Time to resolution of liquid/water stool
Stool for bacterial pathogen culture and viral antigens
Time ready for discharge
Medically confirmed adverse events collected throughout the study period
Record patient use of antibiotics during hospitalization

Full Information

First Posted
January 7, 2022
Last Updated
October 17, 2023
Sponsor
Mead Johnson Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT05247879
Brief Title
Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
September 20, 2023 (Actual)
Study Completion Date
January 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mead Johnson Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis Acute

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Commercial reduced-osmolarity oral rehydration solution (ORS
Arm Type
Active Comparator
Arm Title
VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose containing Oral Rehydration Solution (ORS)
Intervention Description
Oral rehydration solution
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar free - amino acid and electrolyte ORS
Intervention Description
Glucose free oral rehydration solution
Primary Outcome Measure Information:
Title
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.)
Description
Assess change in clinical hydration status from presenting baseline status
Time Frame
every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Secondary Outcome Measure Information:
Title
Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)
Description
5 point scale, 1(no discomfort) minimum, 5 (severe discomfort) maximum
Time Frame
Baseline
Title
Study ORS intake (units)
Time Frame
Every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Title
Use of IV fluids
Time Frame
up to 24 hours or hospital discharge, whichever occurs first
Title
Weight
Description
kg
Time Frame
Every 4 hours up to 24 h or at hospital discharge, whichever occurs first
Title
Participant comfort questionaire
Time Frame
baseline and 24 hours or hospital discharge, whichever occurs first
Title
Parent satisfaction questionnaire
Time Frame
baseline and 24 hours or hospital discharge, whichever occurs first
Title
Frequency of vomiting
Time Frame
every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Title
Frequency episodes of urination
Time Frame
every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Title
Frequency of liquid/watery stool
Time Frame
every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Title
Time to resolution of liquid/water stool
Time Frame
up to 24 hours or hospital discharge, whichever comes first
Title
Stool for bacterial pathogen culture and viral antigens
Time Frame
up to 24 hours or hospital discharge, whichever comes first
Title
Time ready for discharge
Time Frame
At discharge or 48 hours whichever occurs first
Title
Medically confirmed adverse events collected throughout the study period
Time Frame
0 hours through 7 days post discharge
Title
Record patient use of antibiotics during hospitalization
Time Frame
up to 24 hours or hospital discharge, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jami Walker, BS
Phone
812-429-5000
Email
jami.walker@rb.com
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Wu, MD
Phone
812-429-7564
Email
steven.wu@rb.com
Facility Information:
Facility Name
Ramathibodi Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didsaya Sirikittikorn
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didsaya Sirikittikorn
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didsaya Sirikittikorn
Facility Name
Naresuan University Hospital
City
Phitsanulok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didsaya Sirikittikorn

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

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