Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-29 @ 9:29 PM
Study NCT ID:
NCT05291559
Status:
COMPLETED
Last Update Posted:
2022-09-10
First Post:
2022-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: