Clinical trial NCT04677296: Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea, Infantile
Lead sponsor: Entrinsic Bioscience Inc.
Sponsor class: INDUSTRY
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2020-12-21
Enrollment: 312
Sex: MALE
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blinded
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Duration of diarrhea in hospital (hours)
timeFrame: 5 days
Secondary outcomes:
measure: Stool output
timeFrame: 1 day
measure: Total stool output
timeFrame: 5 days
measure: ORS intake in the 1st 24 hours of hospitalization
timeFrame: 1 day
measure: Total ORS intake
timeFrame: 5 days
measure: Unscheduled IV (frequency/ORS group)
timeFrame: 5 days
measure: Treatment failure (frequency/ORS group)
timeFrame: 5 days
measure: Output and frequency of vomiting
timeFrame: 5 days
measure: Change in body weight (between pre-randomization and post-treatment)
timeFrame: 5 days
measure: Urine output in the 1st 24 hours of hospitalization (g/kg body wt.)
timeFrame: 1 day
measure: Total urine output during hospitalization
timeFrame: 5 days
measure: Documented infectious agent
timeFrame: 5 days
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDR,B
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Tahmeed Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.