Actively Recruiting
Growth and Tolerance of Plant-based Enteral Formulas in Children Ages 12-17 Months.
Led by Kate Farms Inc · Updated on 2026-04-14
40
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
K
Kate Farms Inc
Lead Sponsor
N
Nationwide Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Growth and Tolerance of Plant-based Enteral Formulas in Children Ages 12-17 Months.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 12 through 17 months (corrected age for premature infants)
- Weight-for-length z score of -1.5 or higher at enrollment
- Receiving at least 80% of total energy intake from formula feeding at enrollment and expected to continue for 24 weeks
- Families willing and able to follow study requirements
- Written informed consent from parent or legal guardian
- Parent/caregiver or legal guardian able to read, write, and understand English
You will not qualify if you...
- Known or suspected complex gastrointestinal anomalies or dysfunction, liver or kidney dysfunction, or inherited metabolic disorders
- Suspected or diagnosed malabsorption conditions (e.g., cystic fibrosis)
- Children with tracheostomy or receiving oxygen via nasal cannula or on diuretics
- Known or suspected genetic or metabolic conditions affecting growth or body measurements
- Expected to get more than 20% of energy from non-formula nutrition sources (solids, expressed breast milk, or parenteral nutrition)
- Energy needs less than 80 kcal/kg/day
- Breastfeeding more than twice daily
- Likely to have major surgery during study
- Nasogastric tube unlikely to be replaced by gastrostomy tube during study
- Investigator doubts parent/caregiver ability to comply with protocol
- Parent younger than legal age to consent
- Known allergy to pea protein, soy, or peanuts
- Parent or sibling with known allergy to pea protein, soy, or peanuts
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
T
Taelor Shepherd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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