| Protocol No: | ECCT/18/06/01 | Date of Protocol: | 07-05-2018 |
| Study Title: | Safety, Acceptability, and Feasibility of enterade® in children at risk for environmental enteric dysfunction in Kakamega County, Kenya |
| Study Objectives: | Primary Objective: To determine the safety of AA-ORS among children with mild to moderate stunting, administered as a daily dose over 2 weeks, ad libitum up to 237 ml in 3 hours. Safety assessment in children will compare adverse event (AE) and serious adverse event (SAE) rates and changes to dietary and digestive habits between children receiving AA-ORS versus an inactive placebo solution containing no amino acids. Primary Objective: To determine the feasibility and well-tolerated dose of AA-ORS among children with mild to moderate growth stunting administered as a daily dose over 2 weeks, ad libitum up to 237 ml in 3 hours. User preferences among children include average daily volume consumed over days, trends in volume consumed, and factors that influence children’s willingness and ability to ingest the product as intended. Secondary Objective: To determine the perceptions among caregivers on the use and acceptability of this product as a potential intervention for EED. Acceptability by caregivers includes factors that influence their willingness to have the product used by their children and their perception of their child’s response to its consumption. Exploratory Objective: To determine the impact of AA-ORS on gut dysfunction, metabolism, gut and systemic inflammation, and micronutrient status. Impact of AA-ORS on gut dysfunction, systemic inflammation, and micronutrient status will be assessed by comparing non-invasive biomarker levels in blood samples collected following the intervention. These biomarkers will be assessed in both groups at baseline in order to have setting-specific descriptive data with which to power a future EED efficacy trial.
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| Laymans Summary: | Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in low-resource settings (LRS), which in children has been associated with increased risk of growth stunting, reduced cognitive development, and reduced oral vaccine responsiveness. An effective EED therapeutic would offer an opportunity to improve child growth and development in LRS. One promising intervention, enterade® (an amino acid–based oral rehydration solution [AA-ORS]), is a medical food product already sold in the United States. It consists of oral rehydration salts and a proprietary blend of amino acids designed to restore gut function, improve nutrient and electrolyte absorption, and improve barrier integrity. There is evidence that this AA-ORS reduces inflammation and promotes healing of damaged intestinal epithelium in murine models of intestinal damage (irradiated gut), and it may provide benefit to pediatric EED patients. Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure. We will conduct a randomized, double-blinded, placebo-controlled pilot study in Kakamega County, Kenya, to assess the safety, feasible dosage, and acceptability/tolerability of the product in the target population (children aged 12–24 months) and their caregivers.
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| Abstract of Study: | Environmental enteric dysfunction (EED) is an intestinal disorder common among people living in low-resource settings (LRS), which in children has been associated with increased risk of growth stunting, reduced cognitive development, and reduced oral vaccine responsiveness. An effective EED therapeutic would offer an opportunity to improve child growth and development in LRS. One promising intervention, enterade® (an amino acid–based oral rehydration solution [AA-ORS]), is a medical food product already sold in the United States. It consists of oral rehydration salts and a proprietary blend of amino acids designed to restore gut function, improve nutrient and electrolyte absorption, and improve barrier integrity. There is evidence that this AA-ORS reduces inflammation and promotes healing of damaged intestinal epithelium in murine models of intestinal damage (irradiated gut), and it may provide benefit to pediatric EED patients. Supplementation of amino acids may lessen or improve intestinal injury related to enteric illnesses commonly experienced in settings of poor hygiene and sanitation infrastructure. We will conduct a randomized, double-blinded, placebo-controlled pilot study in Kakamega County, Kenya, to assess the safety, feasible dosage, and acceptability/tolerability of the product in the target population (children aged 12–24 months) and their caregivers.
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