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

Diarrhea, Infantile Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677296
• Other study ID #: PR-17028
• Status: Completed
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: September 5, 2022

Study information

• Verified date: March 2023
• Source: Entrinsic Bioscience Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: September 5, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea, Infantile

Intervention

Other:
• VS002A
Amino acid based ORS/Medical food
• WHO-ORS
WHO Oral rehydration solution, which is glucose based

Locations

Country	Name	City	State
Bangladesh	ICDDR,B	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Entrinsic Bioscience Inc.	International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

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