Growth and Tolerance of Plant-based Enteral Formulas in Children Ages 12-17 Months.
Growth and Enteral Tolerance of Plant-Based Enteral Formulas: A Prospective Study
Kate Farms Inc
40 participants
Mar 13, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Children, male or female, aged 12 through 17 months (for premature infants, we will use corrected age)
- Children with a weight-for-length z score between ≥ -1.5 at enrolment
- Children obtaining via formula feeding ≥ 80% of their total energy intake at enrolment and expected to continue to require such formula intake for the next 24 weeks
- Children from families who are willing and able to comply with the requirements of the protocol
- Written informed consent from the parent or legal guardian
- Parent/caregiver or legal guardian must be able to read, write, and understand English
Exclusion Criteria10
- Children with tracheostomy and/or inspired oxygen via nasal cannula or children receiving diuretics.
- Children with known or suspected genetic and/or metabolic inborn errors of metabolism conditions known to interfere with growth or body dysmorphology that can interfere with obtaining standard anthropometric measurements (weight, length, head circumference, and arm circumference)
- At study entry, children expected to consume on average more than 20% of their energy intake from non-formula sources of nutrition: solids, expressed breast milk and /or parenteral nutrition.
- Child requiring or expected to have an energy requirement < 80 kcal/kg per day - Breastfeeding child (who is feeding at the breast > 2 times per day)
- Child likely to undergo major surgery during the duration of the study
- Child with a nasogastric tube that is unlikely to get a gastrostomy tube during the duration of the study
- Principal Investigator's uncertainty about the willingness or ability of the parent/caregiver to comply with the protocol requirements
- Children whose parent is younger than the legal age of consent
- Children with known allergy to pea protein or soy or peanuts.
- Children with a parent or a sibling with a known allergy to pea protein or soy or peanuts.
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07231705