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

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

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

1. To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1 and 2 years of age
2. 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

1. To assess the adherence to the regimen of 237ml (8 oz) of Enterade daily in children aged 1 to 2 years.
2. To assess Enterade (VS001) efficacy by comparing improvements in fecal measures of intestinal inflammation between Enterade (VS001) and placebo.

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