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A Pilot Study of Enterade (VS001), an Oral Amino Acid Formulation, in Malnourished Bangladeshi Children with
Masud Alam1,2, Tahsin Ferdous1, Rifat Ara1,3
1Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
Insights
A new medical food, VS001, containing amino acids, was found to be acceptable and well-tolerated in children with environmental enteric dysfunction (EED). Further trials are recommended due to observed improvements in gut permeability.
Area of Science:
- Pediatrics
- Gastroenterology
- Nutritional Science
Background:
- Environmental enteric dysfunction (EED) is a prevalent condition in low-income countries, causing intestinal inflammation and permeability, leading to growth and neurodevelopmental deficits.
- Currently, no effective treatments exist for EED, highlighting the urgent need for therapeutic interventions.
- VS001, a medical food beverage with free amino acids, has demonstrated potential in preclinical models to reduce intestinal inflammation and enhance gut barrier function.
Purpose of the Study:
- To evaluate the acceptability and tolerability of VS001 in Bangladeshi children aged 1-2 years with EED.
- To assess the impact of VS001 on key biomarkers of EED, including intestinal permeability and inflammation markers.
- To gather preliminary data supporting the potential efficacy of VS001 for future larger clinical trials.
Main Methods:
- A double-blind, placebo-controlled pilot study involving 20 children (10 per arm) aged 1-2 years.
- Participants received either VS001 or a placebo beverage daily for 14 days.
- Acceptability and tolerability were assessed through parental surveys and adverse event monitoring, while EED biomarkers (lactulose-mannitol ratio, fecal lactoferrin, alpha-antitrypsin, myeloperoxidase, neopterin) were measured.
Main Results:
- VS001 was found to be acceptable to parents and generally well-tolerated, with minimal, mild adverse events reported.
- Caregivers reported convenience and ease of administration, with no negative impact on children's appetite.
- While not statistically significant, the active VS001 group showed a trend towards decreased lactulose-mannitol ratios, indicating improved intestinal permeability compared to the placebo group.
Conclusions:
- VS001 presents as an acceptable and well-tolerated intervention for children experiencing environmental enteric dysfunction (EED).
- The observed trend of reduced intestinal permeability warrants further investigation in larger, powered clinical trials.
- VS001 holds promise as a potential therapeutic option for managing EED and its associated complications.
Abstract:
Environmental enteric dysfunction (EED) is a subacute syndrome characterized by increased intestinal inflammation and permeability that affects children in low-income countries. It is associated with growth and neurodevelopmental deficits, and there is currently no known treatment for EED. VS001 (AmiLyfe Bioscience, LLC, Norwood, MA) is a medical food (beverage) containing free amino acids that has been shown to decrease enteric inflammation and improve gut permeability in murine models. We conducted a double-blind, placebo-controlled pilot study to assess the acceptability and tolerability of VS001 in Bangladeshi children aged 1-2 years (n = 10 per arm). We also examined the effects on EED biomarkers (lactulose-mannitol (LM) ratio, fecal lactoferrin, alpha-antitrypsin, myeloperoxidase, and neopterin). Participants received 8 oz. of VS001 or an identical vehicle without amino acids daily for 14 days. Tolerability and acceptability were measured using parental surveys and daily in-home adverse event monitoring. Subjects took an average of 118 minutes to complete the dose each day. Caregivers found the product convenient and easy to administer and either agreed or strongly agreed that they would give this product to their child again. None reported that the intervention negatively affected their child's appetite. There were three mild adverse events deemed possibly related to the intervention, with two occurring in the active arm and one in the control arm. Children in the active arm exhibited a nonsignificant decrease in LM ratios (a marker of intestinal permeability) after treatment compared with the control arm (0.19-0.08 versus 0.19-0.17; P = 0.16). VS001 was acceptable to parents and reasonably well tolerated. Given the decrease in permeability observed in the active arm, a larger trial is warranted.
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