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

Entrinsic Bioscience

Status: Completed

Conditions: Diarrhea, Infantile

Treatments: Other: WHO-ORS; Other: VS002A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04677296

PR-17028

Details and patient eligibility

About

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

Enrollment: 312 patients

Sex: Male

Ages: 6 to 36 months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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312 participants in 2 patient groups

VS002A

Experimental group

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.

Treatment:

Other: VS002A

Standard WHO-ORS

Active Comparator group

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.

Treatment:

Other: WHO-ORS