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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
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This is a pilot study to assess the feasibility and acceptability of a trial of Enterade (VS001) to treat environmental enteric dysfunction in children from a low-income setting. Preliminary data on efficacy will also be obtained.
Primary Objectives
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enterade (VS001) | Experimental | 237 mL (8 fluid oz) per os, once daily for 14 days |
|
| Placebo | Placebo Comparator | 237 mL (8 fluid oz) per os, once daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enterade | Dietary Supplement | Enterade is a glucose-free, amino acid-based medical food containing specific amino acids (aspartic acid, valine, serine, threonine and tyrosine) in addition to electrolytes and a non-sugar sweetener. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in appetite | Parents will complete a study specific survey which will include questions about child's interest in food and food intake which will yield an appetite score. | Baseline to 14 days |
| Change in gastrointestinal health | Parents will complete a study specific survey which will include questions about child's gastrointestinal symptoms such as diarrhea, vomiting, nausea, bloating, or constipation to yield a gastrointestinal health score. | Baseline to 14 days |
| Change in 2 hour Lactulose mannitol ratio | Assessment of Lactulose mannitol ratio at baseline and day 14 | Baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Residual intervention volume | Summation of daily residual volume of unconsumed study product | 14 days |
| Fecal lactoferrin | Assessment of fecal lactoferrin concentration at baseline and day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey R Donowitz, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka | Bangladesh |
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| Placebo | Dietary Supplement | The placebo is an identical product to Enterade except without added amino acids. |
|
| 14 days |
| Fecal myeloperoxidase | Assessment of fecal myeloperoxidase concentration at baseline and day 14 | 14 days |
| Fecal neopterin | Assessment of fecal neopterin concentration at baseline and day 14 | 14 days |
| Fecal Reg 1 beta | Assessment of fecal Reg 1 beta concentration at baseline and day 14 | 14 days |