The INICIO-Guatemala Study

The goal of this randomized controlled trial (RCT) is to evaluate an intestinal health-targeted nutritional intervention and a caregiver training program, individually and combined, on childhood neurodevelopment (ND) in rural southwest Guatemala. The main questions it aims to answer are: what is the impact of an intestinal-targeted nutritional intervention on child ND and what is the added benefit of a caregiver intervention on child ND. The primary endpoint is the Mullen Scales of Early Learning (MSEL) Early Learning Composite (ELC) Score at 24 months. Secondary endpoints include MSEL subdomain scores (gross motor, fine motor, expressive language, receptive language, visual reception). Researchers will compare child ND between the four study arms using a factorial design: (1) intestinal health-targeted nutritional intervention, (2) caregiving training program, (3) combined intestinal health-targeted nutritional intervention and caregiving training program, and (4) active control. Participants will be randomized as mother-child dyads at 6 months of age and followed until 24 months of age.

NCT Number	NCT07383428
Lead Sponsor	University of North Carolina, Chapel Hill Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions	Development, Child
Enrollment	400 participants
Start Date	2026-07-02
Primary Completion	2030-06-15 (estimated)
Study Completion	2030-06-15 (estimated)
Updated on ClinicalTrials.gov	2026-07-24