Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh

Study Overview
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Brief Summary
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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.

Detailed Description
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Primary Objectives To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1 and 2 years of age To assess the efficacy of Enterade (VS001) in treatment of environmental enteric dysfunction by comparing improvements in 2-h lactulose mannitol ratio between Enterade (VS001) and a placebo. Secondary Objectives To assess the adherence to the regimen of 237ml (8 oz) of Enterade daily in children aged 1 to 2 years. To assess Enterade (VS001) efficacy by comparing improvements in fecal measures of intestinal inflammation between Enterade (VS001) and placebo.

Official Title
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Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh

Conditions
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Environmental Enteric Dysfunction

Intervention / Treatment
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* Dietary Supplement: Enterade
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Length-for-age Z score (LAZ) between -1 and -3 standard deviations Lactulose mannitol ratio >0.09 Exclusion Criteria: Presence of known congenital or chronic diseases other than malnutrition Diarrhea (> 3 unformed stools in a 24-hour window) in the 7 days prior to screening Anticipated unavailability for study visits A sibling previously enrolled in this study

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enterade (VS001)<br>237 mL (8 fluid oz) per os, once daily for 14 days | Dietary Supplement: Enterade<br>* 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.<br>* Other names: VS001;|
| Placebo Comparator: Placebo<br>237 mL (8 fluid oz) per os, once daily for 14 days | Dietary Supplement: Placebo<br>* The placebo is an identical product to Enterade except without added amino acids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |