Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

March 22, 2024 updated by: Mead Johnson Nutrition

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.)
Time Frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)
Time Frame: Baseline
5 point scale, 1(no discomfort) minimum, 5 (severe discomfort) maximum
Baseline
Study ORS intake (units)
Time Frame: Every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Use of IV fluids
Time Frame: up to 24 hours or hospital discharge, whichever occurs first
up to 24 hours or hospital discharge, whichever occurs first
Weight
Time Frame: Every 4 hours up to 24 h or at hospital discharge, whichever occurs first
kg
Every 4 hours up to 24 h or at hospital discharge, whichever occurs first
Participant comfort questionaire
Time Frame: baseline and 24 hours or hospital discharge, whichever occurs first
baseline and 24 hours or hospital discharge, whichever occurs first
Parent satisfaction questionnaire
Time Frame: baseline and 24 hours or hospital discharge, whichever occurs first
baseline and 24 hours or hospital discharge, whichever occurs first
Frequency of vomiting
Time Frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Frequency episodes of urination
Time Frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Frequency of liquid/watery stool
Time Frame: every 4 hours up to 24 hours or hospital discharge, whichever occurs first
every 4 hours up to 24 hours or hospital discharge, whichever occurs first
Time to resolution of liquid/water stool
Time Frame: up to 24 hours or hospital discharge, whichever comes first
up to 24 hours or hospital discharge, whichever comes first
Stool for bacterial pathogen culture and viral antigens
Time Frame: up to 24 hours or hospital discharge, whichever comes first
up to 24 hours or hospital discharge, whichever comes first
Time ready for discharge
Time Frame: At discharge or 48 hours whichever occurs first
At discharge or 48 hours whichever occurs first
Medically confirmed adverse events collected throughout the study period
Time Frame: 0 hours through 7 days post discharge
0 hours through 7 days post discharge
Record patient use of antibiotics during hospitalization
Time Frame: up to 24 hours or hospital discharge, whichever comes first
up to 24 hours or hospital discharge, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mead Johnson Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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