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

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Environmental Enteric Dysfunction

Treatments

Dietary Supplement: Enterade

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05291559

HM20023567

Details and patient eligibility

About

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.

Full description

Primary Objectives

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

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

Enrollment

20 patients

Sex

All

Ages

1 to 2 years old

Volunteers

Accepts Healthy Volunteers

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