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

• ClinicalTrials.gov Identifier: NCT04677296
• Recruitment Status: Recruiting
• First Posted: December 21, 2020
• Last Update Posted: August 20, 2021
• Sponsor: Entrinsic Bioscience Inc.
• Collaborator: International Centre for Diarrhoeal Disease Research, Bangladesh
• Information provided by (Responsible Party): Entrinsic Bioscience Inc.

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

Condition or disease	Intervention/treatment	Phase
Diarrhea, Infantile	Other: VS002A; Other: WHO-ORS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 312 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized double blinded
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 16, 2021
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: May 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Duration of diarrhea in hospital (hours) [ Time Frame: 5 days ]
   number of hours of diarrhea after randomization

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 36 Months (Child)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Measuring stool output on a diaper on female children will create a bias since it will be mixed with urine.
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Tahmeed Ahmed, MD; +88(017)13093848; tahmeed@icddrb.org

Contact: Pradip Bardhan, MD; +88(017)13093848; pradip.bardhan@gmail.com

Locations

Bangladesh

ICDDR,B; Recruiting

Dhaka, Bangladesh

Contact: Pradip Bardhan, MD +88(017)13093848 pradip.bardhan@gmail.com

Contact: Rina Das, MD +8801716160451 rina.das@icddrb.org

Sponsors and Collaborators

Entrinsic Bioscience Inc.

International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

• Principal Investigator: Tahmeed Ahmed, MD; International Centre for Diarrhoeal Disease Research, Bangladesh

More Information

• Responsible Party: Entrinsic Bioscience Inc.
• ClinicalTrials.gov Identifier: NCT04677296
• Other Study ID Numbers: PR-17028
• First Posted: December 21, 2020
• Last Update Posted: August 20, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diarrhea; Diarrhea, Infantile; Signs and Symptoms, Digestive