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Growth and Tolerance of Plant-based Enteral Formulas in Children Ages 12-17 Months.
Sponsor: Kate Farms Inc
Summary
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.
Official title: Growth and Enteral Tolerance of Plant-Based Enteral Formulas: A Prospective Study
Key Details
Gender
All
Age Range
12 Months - 17 Months
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-03-13
Completion Date
2028-03-31
Last Updated
2026-04-14
Healthy Volunteers
No
Interventions
Kate Farms Standard 1.2 or Peptide 1.0
Kate Farms Standard 1.2 or Peptide 1.0 formulas will be provided by mouth or via tubefeeding. Study children will be fed the formula for a period of up through 24 weeks.
Locations (1)
Nationwide Children's Hospital
Columbus, Ohio, United States