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Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children

Primary Purpose

Diarrhea, Infantile

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
VS002A
WHO-ORS
Sponsored by
Entrinsic Bioscience Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea, Infantile

Eligibility Criteria

6 Months - 36 Months (Child)MaleDoes not accept healthy volunteers

Inclusion criteria:

  1. Age: 6 months - 36 months,
  2. Duration of diarrhea ≤48 hours,
  3. Some dehydration (judged clinically according to the "Dhaka method"),
  4. Written informed consent by either parent/guardian.

Exclusion criteria:

  1. Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ <-3 or presence of nutritional edema)
  2. Patients with diarrhea due to cholera.
  3. Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.)
  4. Bloody diarrhea
  5. Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.)
  6. Requirement of additional intravenous fluids after being provided with an IV for 4 hours on admission if severely dehydrated
  7. Has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization.

Sites / Locations

  • ICDDR,B

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VS002A

Standard WHO-ORS

Arm Description

Amino acid based ORS/medical food (VS002A). Initial treatment dosing with VS002A will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss.

Standard WHO-ORS. Initial treatment dosing with WHO-ORS will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss.

Outcomes

Primary Outcome Measures

Duration of diarrhea in hospital (hours)
number of hours of diarrhea after randomization

Secondary Outcome Measures

Stool output
Stool output in the 1st 24 hours of hospitalization (g/kg body wt.), divided into two 12-hour periods
Total stool output
Total amount of stool output during the study
ORS intake in the 1st 24 hours of hospitalization
Amount of intervention drink consumed in the first 24 hours after randomization
Total ORS intake
Amount of intervention drink consumed throughout the duration of the study
Unscheduled IV (frequency/ORS group)
Frequency of IV fluids between he 2 groups
Treatment failure (frequency/ORS group)
Frequency of treatment failures between the two groups
Output and frequency of vomiting
Amount and frequency of vomiting between the two groups
Change in body weight (between pre-randomization and post-treatment)
Body weight at randomization and post treatment
Urine output in the 1st 24 hours of hospitalization (g/kg body wt.)
Amount of urine in the first 24 hours after randomization
Total urine output during hospitalization
Total urine output (g/kg body wt.)
Documented infectious agent
Stool culture and recording of infectious agent causing the diarrhea

Full Information

First Posted
November 17, 2020
Last Updated
March 21, 2023
Sponsor
Entrinsic Bioscience Inc.
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT04677296
Brief Title
Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children
Official Title
Clinical Trial to Compare the Efficacy and Safety of a Multiple Amino-acid Based ORS "VS002A" With the Standard WHO-ORS in the Management of Non-cholera Acute Watery Diarrhea in Infants and Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Entrinsic Bioscience Inc.
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

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

5. Study Description

Brief Summary
Randomized double blinded clinical trial comparing amino acid based oral rehydration solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in pediatric population

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Infantile

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double blinded
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VS002A
Arm Type
Experimental
Arm Description
Amino acid based ORS/medical food (VS002A). Initial treatment dosing with VS002A will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss.
Arm Title
Standard WHO-ORS
Arm Type
Active Comparator
Arm Description
Standard WHO-ORS. Initial treatment dosing with WHO-ORS will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss.
Intervention Type
Other
Intervention Name(s)
VS002A
Intervention Description
Amino acid based ORS/Medical food
Intervention Type
Other
Intervention Name(s)
WHO-ORS
Intervention Description
WHO Oral rehydration solution, which is glucose based
Primary Outcome Measure Information:
Title
Duration of diarrhea in hospital (hours)
Description
number of hours of diarrhea after randomization
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Stool output
Description
Stool output in the 1st 24 hours of hospitalization (g/kg body wt.), divided into two 12-hour periods
Time Frame
1 day
Title
Total stool output
Description
Total amount of stool output during the study
Time Frame
5 days
Title
ORS intake in the 1st 24 hours of hospitalization
Description
Amount of intervention drink consumed in the first 24 hours after randomization
Time Frame
1 day
Title
Total ORS intake
Description
Amount of intervention drink consumed throughout the duration of the study
Time Frame
5 days
Title
Unscheduled IV (frequency/ORS group)
Description
Frequency of IV fluids between he 2 groups
Time Frame
5 days
Title
Treatment failure (frequency/ORS group)
Description
Frequency of treatment failures between the two groups
Time Frame
5 days
Title
Output and frequency of vomiting
Description
Amount and frequency of vomiting between the two groups
Time Frame
5 days
Title
Change in body weight (between pre-randomization and post-treatment)
Description
Body weight at randomization and post treatment
Time Frame
5 days
Title
Urine output in the 1st 24 hours of hospitalization (g/kg body wt.)
Description
Amount of urine in the first 24 hours after randomization
Time Frame
1 day
Title
Total urine output during hospitalization
Description
Total urine output (g/kg body wt.)
Time Frame
5 days
Title
Documented infectious agent
Description
Stool culture and recording of infectious agent causing the diarrhea
Time Frame
5 days

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Measuring stool output on a diaper on female children will create a bias since it will be mixed with urine.
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age: 6 months - 36 months, Duration of diarrhea ≤48 hours, Some dehydration (judged clinically according to the "Dhaka method"), Written informed consent by either parent/guardian. Exclusion criteria: Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ <-3 or presence of nutritional edema) Patients with diarrhea due to cholera. Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.) Bloody diarrhea Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.) Requirement of additional intravenous fluids after being provided with an IV for 4 hours on admission if severely dehydrated Has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tahmeed Ahmed, MD
Organizational Affiliation
International Centre for Diarrhoeal Disease Research, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICDDR,B
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36008819
Citation
Das R, Sobi RA, Sultana AA, Nahar B, Bardhan PK, Luke L, Fontaine O, Ahmed T. A double-blind clinical trial to compare the efficacy and safety of a multiple amino acid-based ORS with the standard WHO-ORS in the management of non-cholera acute watery diarrhea in infants and young children: "VS002A" trial protocol. Trials. 2022 Aug 25;23(1):706. doi: 10.1186/s13063-022-06601-5.
Results Reference
derived

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Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children

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