Environmental Enteric Dysfunction
Conditions
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.
Interventions
DIETARY_SUPPLEMENTEnterade
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.
DIETARY_SUPPLEMENTPlacebo
The placebo is an identical product to Enterade except without added amino acids.
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 2 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 2 hour Lactulose mannitol ratio | Baseline to 14 days | Assessment of Lactulose mannitol ratio at baseline and day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal neopterin | 14 days | Assessment of fecal neopterin concentration at baseline and day 14 |
| Residual intervention volume | 14 days | Summation of daily residual volume of unconsumed study product |
| Fecal Reg 1 beta | 14 days | Assessment of fecal Reg 1 beta concentration at baseline and day 14 |
| Fecal lactoferrin | 14 days | Assessment of fecal lactoferrin concentration at baseline and day 14 |
| Fecal myeloperoxidase | 14 days | Assessment of fecal myeloperoxidase concentration at baseline and day 14 |
Countries
Bangladesh
Outcome results
None listed