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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
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.
The placebo is an identical product to Enterade except without added amino acids.
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
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.
Time frame: 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.
Time frame: Baseline to 14 days
Change in 2 hour Lactulose mannitol ratio
Assessment of Lactulose mannitol ratio at baseline and day 14
Time frame: Baseline to 14 days
Residual intervention volume
Summation of daily residual volume of unconsumed study product
Time frame: 14 days
Fecal lactoferrin
Assessment of fecal lactoferrin concentration at baseline and day 14
Time frame: 14 days
Fecal myeloperoxidase
Assessment of fecal myeloperoxidase concentration at baseline and day 14
Time frame: 14 days
Fecal neopterin
Assessment of fecal neopterin concentration at baseline and day 14
Time frame: 14 days
Fecal Reg 1 beta
Assessment of fecal Reg 1 beta concentration at baseline and day 14
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Time frame: 14 days