Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT05291559
Brief 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.
Study:
NCT05291559
Study Brief:
Protocol Section:
NCT05291559