Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in gastrointestinal health
Study Overview
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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Enterade (VS001)
237 mL (8 fluid oz) per os, once daily for 14 days
Intervention: Enterade (Dietary Supplement)
Placebo
237 mL (8 fluid oz) per os, once daily for 14 days
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Change in gastrointestinal health
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to 14 days
Assessment of Lactulose mannitol ratio at baseline and day 14
Secondary Outcomes
- Residual intervention volume(14 days)
- Fecal myeloperoxidase(14 days)
- Fecal neopterin(14 days)
- Fecal lactoferrin(14 days)
- Fecal Reg 1 beta(14 days)