Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala

This randomized, open‐label pilot study will compare a modified food supplement withNutri Listo, a small‐quantity lipid‐based nutrient supplement currently used inGuatemala. Approximately 36 children aged 12 to 24 months with mild‐to‐moderate stuntingwill be enrolled and assigned to one of two study groups.The modified formulation combines commonly consumed food ingredients and nutrients,including peanut, green banana, chickpea, whey protein, vegetable oil, vitamins, andminerals. The comparison group will receive Nutri Listo. Both groups will receive one30‐gram sachet per day for 21 days.The study is primarily designed to evaluate whether the modified formulation can befeasibly delivered and is acceptable and well tolerated under home‐based conditions.Caregivers will be contacted regularly during the intervention to assess productconsumption and gastrointestinal symptoms. Stool samples will be collected near baselineand at the end of the intervention to explore short‐term changes in markers of intestinalinflammation, microbial fermentation, and gut microbiome composition.This pilot is intended to generate feasibility and preliminary biological data that caninform the design of larger studies. It is not powered to determine effects on childgrowth or other clinical outcomes.