Clinical Research Directory

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

Sponsor: Wuqu' Kawoq, Maya Health Alliance

Summary

The goal of this clinical trial is to learn whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala. The study will also explore whether the food is associated with short-term changes in stool markers related to gut inflammation and microbial activity. The main questions are: * Will children accept and regularly eat the modified food supplement? * What stomach or bowel symptoms, if any, occur while children eat the supplement? * Do stool markers related to gut health change over the short study period? Researchers will compare the modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement already used in Guatemala. Children will be assigned by chance to one of the two groups. Participants will: * Complete a brief taste and acceptability test * Eat one 30-gram sachet of the assigned food each day for 21 days * Have their caregiver receive brief phone or WhatsApp check-ins during the study * Provide a stool sample near the beginning and end of the study This is a small pilot study. It is designed to assess feasibility, acceptability, tolerability, and early biological signals rather than to determine whether the modified food improves growth or other clinical outcomes.

Official title: A Pilot Study to Evaluate the Acceptability, Tolerability, and Short-Term Biological Signals of a Modified Therapeutic Food Compared to a Standard Lipid-Based Nutrient Supplement in Children Aged 12-24 Months in Rural Guatemala

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