Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2024-01-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroenteritis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Commercial reduced-osmolarity oral rehydration solution (ORS

Group Type ACTIVE_COMPARATOR

Glucose containing Oral Rehydration Solution (ORS)

Intervention Type DIETARY_SUPPLEMENT

Oral rehydration solution

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

Group Type EXPERIMENTAL

Sugar free - amino acid and electrolyte ORS

Intervention Type DIETARY_SUPPLEMENT

Glucose free oral rehydration solution

Interventions

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Glucose containing Oral Rehydration Solution (ORS)

Oral rehydration solution

Intervention Type DIETARY_SUPPLEMENT

Sugar free - amino acid and electrolyte ORS

Glucose free oral rehydration solution

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No