An interventional study of Enterade and Placebo in Environmental Enteric Dysfunction, sponsored by Virginia Commonwealth University. Completed at 1 site in Bangladesh. Open to participants aged 1 Year to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Treatment
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
Secondary Objectives
Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
237 mL (8 fluid oz) per os, once daily for 14 days
Dietary Supplement: Enterade
237 mL (8 fluid oz) per os, once daily for 14 days
Dietary Supplement: Placebo
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.
Also known as: VS001
The placebo is an identical product to Enterade except without added amino acids.
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
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University