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

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.

Study Overview

• Status: Completed
• Conditions: Environmental Enteric Dysfunction
• Intervention / Treatment: Dietary supplement: Enterade; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enterade (VS001); 237 mL (8 fluid oz) per os, once daily for 14 days	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.; Other Names: VS001
Placebo Comparator: Placebo; 237 mL (8 fluid oz) per os, once daily for 14 days	Dietary supplement: Placebo; The placebo is an identical product to Enterade except without added amino acids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in 2 hour Lactulose mannitol ratio	Assessment of Lactulose mannitol ratio at baseline and day 14	Baseline to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual intervention volume	Summation of daily residual volume of unconsumed study product	14 days
Fecal lactoferrin	Assessment of fecal lactoferrin concentration at baseline and day 14	14 days
Fecal myeloperoxidase	Assessment of fecal myeloperoxidase concentration at baseline and day 14	14 days
Fecal neopterin	Assessment of fecal neopterin concentration at baseline and day 14	14 days
Fecal Reg 1 beta	Assessment of fecal Reg 1 beta concentration at baseline and day 14	14 days

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh
• Investigators: Principal Investigator: Jeffrey R Donowitz, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HM20023567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No