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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
312
ICDDR,B
Dhaka, Bangladesh
Duration of diarrhea in hospital (hours)
number of hours of diarrhea after randomization
Time frame: 5 days
Stool output
Stool output in the 1st 24 hours of hospitalization (g/kg body wt.), divided into two 12-hour periods
Time frame: 1 day
Total stool output
Total amount of stool output during the study
Time frame: 5 days
ORS intake in the 1st 24 hours of hospitalization
Amount of intervention drink consumed in the first 24 hours after randomization
Time frame: 1 day
Total ORS intake
Amount of intervention drink consumed throughout the duration of the study
Time frame: 5 days
Unscheduled IV (frequency/ORS group)
Frequency of IV fluids between he 2 groups
Time frame: 5 days
Treatment failure (frequency/ORS group)
Frequency of treatment failures between the two groups
Time frame: 5 days
Output and frequency of vomiting
Amount and frequency of vomiting between the two groups
Time frame: 5 days
Change in body weight (between pre-randomization and post-treatment)
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Body weight at randomization and post treatment
Time frame: 5 days
Urine output in the 1st 24 hours of hospitalization (g/kg body wt.)
Amount of urine in the first 24 hours after randomization
Time frame: 1 day
Total urine output during hospitalization
Total urine output (g/kg body wt.)
Time frame: 5 days
Documented infectious agent
Stool culture and recording of infectious agent causing the diarrhea
Time frame: 5 days