Diarrhea, Infantile
Conditions
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
Interventions
OTHERVS002A
Amino acid based ORS/Medical food
OTHERWHO-ORS
WHO Oral rehydration solution, which is glucose based
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
Entrinsic Bioscience Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized double blinded
Eligibility
Sex/Gender
MALE
Age
6 Months to 36 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of diarrhea in hospital (hours) | 5 days | number of hours of diarrhea after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total stool output | 5 days | Total amount of stool output during the study |
| ORS intake in the 1st 24 hours of hospitalization | 1 day | Amount of intervention drink consumed in the first 24 hours after randomization |
| Total ORS intake | 5 days | Amount of intervention drink consumed throughout the duration of the study |
| Unscheduled IV (frequency/ORS group) | 5 days | Frequency of IV fluids between he 2 groups |
| Treatment failure (frequency/ORS group) | 5 days | Frequency of treatment failures between the two groups |
| Stool output | 1 day | Stool output in the 1st 24 hours of hospitalization (g/kg body wt.), divided into two 12-hour periods |
| Change in body weight (between pre-randomization and post-treatment) | 5 days | Body weight at randomization and post treatment |
| Urine output in the 1st 24 hours of hospitalization (g/kg body wt.) | 1 day | Amount of urine in the first 24 hours after randomization |
| Total urine output during hospitalization | 5 days | Total urine output (g/kg body wt.) |
| Documented infectious agent | 5 days | Stool culture and recording of infectious agent causing the diarrhea |
| Output and frequency of vomiting | 5 days | Amount and frequency of vomiting between the two groups |
Countries
Bangladesh
Outcome results
None listed