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

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

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

Study Overview

• Status: Completed
• Conditions: Diarrhea, Infantile
• Intervention / Treatment: Other: VS002A; Other: WHO-ORS

• Study Type: Interventional
• Enrollment (Actual): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tahmeed Ahmed, MD; Phone Number: +88(017)13093848; Email: tahmeed@icddrb.org
• Study Contact Backup: Name: Pradip Bardhan, MD; Phone Number: +88(017)13093848; Email: pradip.bardhan@gmail.com

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Icddr,b

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: VS002A; Amino acid based ORS/Medical food
Active Comparator: Standard 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.	Other: WHO-ORS; WHO Oral rehydration solution, which is glucose based

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of diarrhea in hospital (hours)	number of hours of diarrhea after randomization	5 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Entrinsic Bioscience Inc.
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh
• Investigators: Principal Investigator: Tahmeed Ahmed, MD, International Centre for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): September 5, 2022
• Study Completion (Actual): September 5, 2022

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Diarrhea, Infantile
• Other Study ID Numbers: PR-17028

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