NCT05291559

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 1 Year – 2 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Environmental Enteric Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Enterade	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.
DIETARY_SUPPLEMENT	Placebo	The placebo is an identical product to Enterade except without added amino acids.

Timeline

• Start date: 2022-07-18
• Primary completion: 2022-09-07
• Completion: 2022-09-07
• First posted: 2022-03-22
• Last updated: 2022-09-10

Locations

1 site across 1 country: Bangladesh