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Completed

NCT Number: NCT04677296

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

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

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Key information

Conditions

Diarrhea, Infantile Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 month–36 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

ICDDR,B

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

VS002A

Other

Amino acid based ORS/Medical food

WHO-ORS

Other

WHO Oral rehydration solution, which is glucose based

Primary outcomes

  1. Duration of diarrhea in hospital (hours)

    Time frame: 5 days

    number of hours of diarrhea after randomization

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Entrinsic Bioscience Inc.

Industry

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2020
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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