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 Details — Status: Completed

Administrative data

• NCT number: NCT05291559
• Other study ID #: HM20023567
• Status: Completed
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: September 7, 2022

Study information

• Verified date: September 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Environmental Enteric Dysfunction

Intervention

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.
• Placebo
The placebo is an identical product to Enterade except without added amino acids.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in appetite	Parents will complete a study specific survey which will include questions about child's interest in food and food intake which will yield an appetite score.	Baseline to 14 days
Primary	Change in gastrointestinal health	Parents will complete a study specific survey which will include questions about child's gastrointestinal symptoms such as diarrhea, vomiting, nausea, bloating, or constipation to yield a gastrointestinal health score.	Baseline to 14 days
Primary	Change in 2 hour Lactulose mannitol ratio	Assessment of Lactulose mannitol ratio at baseline and day 14	Baseline to 14 days
Secondary	Residual intervention volume	Summation of daily residual volume of unconsumed study product	14 days
Secondary	Fecal lactoferrin	Assessment of fecal lactoferrin concentration at baseline and day 14	14 days
Secondary	Fecal myeloperoxidase	Assessment of fecal myeloperoxidase concentration at baseline and day 14	14 days
Secondary	Fecal neopterin	Assessment of fecal neopterin concentration at baseline and day 14	14 days
Secondary	Fecal Reg 1 beta	Assessment of fecal Reg 1 beta concentration at baseline and day 14	14 days