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

Not Applicable

Completed

• Conditions: Environmental Enteric Dysfunction
• Interventions: Dietary Supplement: Enterade; Dietary Supplement: Placebo

• Registration Number: NCT05291559
• Lead Sponsor: Virginia Commonwealth University

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 Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-22
• Study Start: 2022-07-18
• Status Verified: 2022-09
• Primary Completion: 2022-09-07
• Study Completion: 2022-09-07
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enterade (VS001)	Enterade	237 mL (8 fluid oz) per os, once daily for 14 days
Placebo	Placebo	237 mL (8 fluid oz) per os, once daily for 14 days

Primary Outcome Measures

Name	Time	Method
Change in gastrointestinal health	Baseline to 14 days	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.
Change in appetite	Baseline to 14 days	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.
Change in 2 hour Lactulose mannitol ratio	Baseline to 14 days	Assessment of Lactulose mannitol ratio at baseline and day 14

Secondary Outcome Measures

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

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh