Growth and Tolerance of Plant-based Enteral Formulas in Children Ages 12-17 Months.

The purpose of this prospective study is to evaluate the growth and enteral tolerance of two pea protein-based formulas from Kate Farms in children aged 12 to 17 months who are expected to meet most of their nutritional needs through formula. It is hypothesized that the Pediatric Standard 1.2 and Pediatric Peptide 1.0 formulas will support healthy growth in children between 1 and 2 years of age. The study will assess the impact of these formulas on growth, tolerance, body composition, micronutrient levels, and gut microbiome health in tube-fed children. Formula will be provided for 24 weeks.

NCT Number	NCT07231705
Lead Sponsor	Kate Farms Inc Collaborators: Nationwide Children's Hospital
Conditions	Formula Dependent Children 1 to 2 Years of Age
Enrollment	40 participants
Start Date	2026-03-13
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-14