VS002A in the Treatment of Acute Watery Diarrhea in Infants and Young Children

NCT06179589 | Completed DMC

• 1 other identifier: PR-17028
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

Background (brief):

• It will be a randomized, double-blind, two cell clinical trial at Dhaka Hospital of icddr,b. Total 312 (156 in each arm) male children aged 6-36 months old with acute (onset \<48 hours) non-bloody watery diarrhea will be included in this study. However, patients with severe malnutrition, any systemic illness, cholera, unwilling to comply with study protocol, remain significantly dehydrated 4 hours after intravenous fluid infusion (if required at start), has documentation of taking antibiotics or antidiarrheal 48 hours before admission will be excluded.
• Intervention arm participants will get amino acid ORS (VS002A) and control arm will get standard glucose based WHO-ORS. Other aspects of clinical managements for diarrhea as per hospital guideline will be similar in both cases and controls

Conditions

Acute Watery Diarrhoea

Outcome Measures

Primary Outcomes (1)

• Duration of diarrhea

  Duration of diarrhea after randomization during hospital stay in hours

  upto 5 days after randomization

Secondary Outcomes (2)

• Stool output

  1st 24 hours

• ORS intake

  1st 24 hours

Study Arms (2)

VS002A

EXPERIMENTAL

Advanced Amino acid-based ORS: VS002A Traditional oral rehydration solutions (ORS) contain sugars which stimulate intestinal sodium and water absorption through a variety of mechanisms. However, it has been under-appreciated that traditional ORS possess no anti-diarrheal functions and may exacerbate infectious diarrheal secretions.

Dietary Supplement: VS002A

WHO-ORS

ACTIVE COMPARATOR

WHO-ORS usually used worldwide in the treatment of diarrhoea.

Dietary Supplement: VS002A

Interventions

VS002A DIETARY_SUPPLEMENT

Amino acid based, glucose free ORS

VS002A; WHO-ORS

Eligibility Criteria

• Age: 6 Months - 36 Months
• Gender Eligibility Details: only male children, since separation of stool and urine is difficult in female children.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 6 months - 36 months,
• Duration of diarrhea ≤48 hours,
• Some dehydration (judged clinically according to the "Dhaka method"),
• Written informed consent by either parent/guardian.

You may not qualify if:

• Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ \<-3 or presence of nutritional edema)
• Patients with diarrhea due to cholera.
• Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.)
• Bloody diarrhea
• Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.)
• Requirement of additional intravenous fluids after being provided with an IV for 4 hours on admission if severely dehydrated
• Has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Entrinsic Bioscience Inc.: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomized, parallel group, clinical trial

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: December 22, 2023
• Study Start: December 1, 2020
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)