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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VS002A | Experimental | 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. |
|
| Standard WHO-ORS | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VS002A | Other | Amino acid based ORS/Medical food |
| |
| WHO-ORS |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of diarrhea in hospital (hours) | number of hours of diarrhea after randomization | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stool output | Stool output in the 1st 24 hours of hospitalization (g/kg body wt.), divided into two 12-hour periods | 1 day |
| Total stool output | Total amount of stool output during the study |
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Inclusion criteria:
Exclusion criteria:
Measuring stool output on a diaper on female children will create a bias since it will be mixed with urine.
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| Name | Affiliation | Role |
|---|---|---|
| Tahmeed Ahmed, MD | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICDDR,B | Dhaka | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36008819 | Derived | Das R, Sobi RA, Sultana AA, Nahar B, Bardhan PK, Luke L, Fontaine O, Ahmed T. A double-blind clinical trial to compare the efficacy and safety of a multiple amino acid-based ORS with the standard WHO-ORS in the management of non-cholera acute watery diarrhea in infants and young children: "VS002A" trial protocol. Trials. 2022 Aug 25;23(1):706. doi: 10.1186/s13063-022-06601-5. |
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| ID | Term |
|---|---|
| D003968 | Diarrhea, Infantile |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C044142 | World Health Organization oral rehydration solution |
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Randomized double blinded
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| Other |
WHO Oral rehydration solution, which is glucose based |
|
| 5 days |
| ORS intake in the 1st 24 hours of hospitalization | Amount of intervention drink consumed in the first 24 hours after randomization | 1 day |
| Total ORS intake | Amount of intervention drink consumed throughout the duration of the study | 5 days |
| Unscheduled IV (frequency/ORS group) | Frequency of IV fluids between he 2 groups | 5 days |
| Treatment failure (frequency/ORS group) | Frequency of treatment failures between the two groups | 5 days |
| Output and frequency of vomiting | Amount and frequency of vomiting between the two groups | 5 days |
| Change in body weight (between pre-randomization and post-treatment) | Body weight at randomization and post treatment | 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 | 1 day |
| Total urine output during hospitalization | Total urine output (g/kg body wt.) | 5 days |
| Documented infectious agent | Stool culture and recording of infectious agent causing the diarrhea | 5 days |