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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2022-09-05

Brief Summary

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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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Detailed Description

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Conditions

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Diarrhea, Infantile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double blinded

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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VS002A

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.

Group Type EXPERIMENTAL

VS002A

Intervention Type OTHER

Amino acid based ORS/Medical food

Standard WHO-ORS

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.

Group Type ACTIVE_COMPARATOR

WHO-ORS

Intervention Type OTHER

WHO Oral rehydration solution, which is glucose based

Interventions

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VS002A

Amino acid based ORS/Medical food

Intervention Type OTHER

WHO-ORS

WHO Oral rehydration solution, which is glucose based

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No