CompletedNot Applicable

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

Bangladesh312 participantsStarted 2021-06-16

Plain-language 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

Who can participate

Age range6 Months – 36 Months

SexMALE

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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.

What they're measuring

Duration of diarrhea in hospital (hours)

Timeframe: 5 days

Trial details

NCT IDNCT04677296

SponsorEntrinsic Bioscience Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-05

View on ClinicalTrials.gov More Diarrhea, Infantile trials