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

Environmental Enteric Dysfunction Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Environmental Enteric Dysfunction
Clinical Trial Details
NCT number NCT05291559
Study type Interventional
Source Virginia Commonwealth University
Contact
Status Completed
Phase N/A
Start date July 18, 2022
Completion date September 7, 2022
View Details
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