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NOT YET RECRUITING
NCT07231705
NA

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

Sponsor: Kate Farms Inc

View on ClinicalTrials.gov

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

2025-12-31

Completion Date

2027-09-30

Last Updated

2025-12-09

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

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.