## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 5003
#### Organization
**Class:** INDUSTRY
**Full Name:** Mead Johnson Nutrition
### Status Module
#### Completion Date
**Date:** 2024-01-18

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-25

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-20

**Type:** ACTUAL

#### Start Date
**Date:** 2022-06-30

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2022-02-21
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-07
**Study First Submit QC Date:** 2022-02-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Mead Johnson Nutrition

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Gastroenteritis Acute

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Dietary Supplement: Glucose containing Oral Rehydration Solution (ORS)

**Label:** Commercial reduced-osmolarity oral rehydration solution (ORS

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Dietary Supplement: Sugar free - amino acid and electrolyte ORS

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

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Commercial reduced-osmolarity oral rehydration solution (ORS

**Description:** Oral rehydration solution

**Name:** Glucose containing Oral Rehydration Solution (ORS)

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

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

**Description:** Glucose free oral rehydration solution

**Name:** Sugar free - amino acid and electrolyte ORS

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Assess change in clinical hydration status from presenting baseline status

**Measure:** 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

#### Secondary Outcomes

**Description:** 5 point scale, 1(no discomfort) minimum, 5 (severe discomfort) maximum

**Measure:** Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.)

**Time Frame:** Baseline

**Measure:** Study ORS intake (units)

**Time Frame:** Every 4 hours up to 24 hours or hospital discharge, whichever occurs first

**Measure:** Use of IV fluids

**Time Frame:** up to 24 hours or hospital discharge, whichever occurs first

**Description:** kg

**Measure:** Weight

**Time Frame:** Every 4 hours up to 24 h or at hospital discharge, whichever occurs first

**Measure:** Participant comfort questionaire

**Time Frame:** baseline and 24 hours or hospital discharge, whichever occurs first

**Measure:** Parent satisfaction questionnaire

**Time Frame:** baseline and 24 hours or hospital discharge, whichever occurs first

**Measure:** Frequency of vomiting

**Time Frame:** every 4 hours up to 24 hours or hospital discharge, whichever occurs first

**Measure:** Frequency episodes of urination

**Time Frame:** every 4 hours up to 24 hours or hospital discharge, whichever occurs first

**Measure:** Frequency of liquid/watery stool

**Time Frame:** every 4 hours up to 24 hours or hospital discharge, whichever occurs first

**Measure:** Time to resolution of liquid/water stool

**Time Frame:** up to 24 hours or hospital discharge, whichever comes first

**Measure:** Stool for bacterial pathogen culture and viral antigens

**Time Frame:** up to 24 hours or hospital discharge, whichever comes first

**Measure:** Time ready for discharge

**Time Frame:** At discharge or 48 hours whichever occurs first

**Measure:** Medically confirmed adverse events collected throughout the study period

**Time Frame:** 0 hours through 7 days post discharge

**Measure:** Record patient use of antibiotics during hospitalization

**Time Frame:** up to 24 hours or hospital discharge, whichever comes first

### Eligibility Module

**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

**Maximum Age:** 5 Years

**Minimum Age:** 1 Year

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bangkok

**Country:** Thailand

**Facility:** Ramathibodi Hospital

**Location 2:**

**City:** Bangkok

**Country:** Thailand

**Facility:** Siriraj Hospital

**Location 3:**

**City:** Chiang Mai

**Country:** Thailand

**Facility:** Maharaj Nakorn Chiang Mai Hospital

**Location 4:**

**City:** Phitsanulok

**Country:** Thailand

**Facility:** Naresuan University Hospital

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6883

- Name: Dehydration

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: HIGH

- As Found: Gastroenteritis

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005759

- Term: Gastroenteritis

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
