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

Not Applicable

Completed

• Conditions: Diarrhea, Infantile
• Interventions: Other: WHO-ORS; Other: VS002A

• Registration Number: NCT04677296
• Lead Sponsor: Entrinsic Bioscience Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-21
• Study Start: 2021-06-16
• Primary Completion: 2022-09-05
• Study Completion: 2022-09-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 312

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard WHO-ORS	WHO-ORS	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.
VS002A	VS002A	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.

Primary Outcome Measures

Name	Time	Method
Duration of diarrhea in hospital (hours)	5 days	number of hours of diarrhea after randomization

Secondary Outcome Measures

Name	Time	Method
Documented infectious agent	5 days	Stool culture and recording of infectious agent causing the diarrhea
Total urine output during hospitalization	5 days	Total urine output (g/kg body wt.)
Total ORS intake	5 days	Amount of intervention drink consumed throughout the duration of the study
Total stool output	5 days	Total amount of stool output during the study
Change in body weight (between pre-randomization and post-treatment)	5 days	Body weight at randomization and post treatment
ORS intake in the 1st 24 hours of hospitalization	1 day	Amount of intervention drink consumed in the first 24 hours after randomization
Stool output	1 day	Stool output in the 1st 24 hours of hospitalization (g/kg body wt.), divided into two 12-hour periods
Unscheduled IV (frequency/ORS group)	5 days	Frequency of IV fluids between he 2 groups
Treatment failure (frequency/ORS group)	5 days	Frequency of treatment failures between the two groups
Output and frequency of vomiting	5 days	Amount and frequency of vomiting between the two groups
Urine output in the 1st 24 hours of hospitalization (g/kg body wt.)	1 day	Amount of urine in the first 24 hours after randomization

Trial Locations

Locations (1)

ICDDR,B; 🇧🇩 Dhaka, Bangladesh