Plant-based (pea protein) enteral formulas for children 12–17 months
Official title: Growth and Enteral Tolerance of Plant-Based Enteral Formulas: A Prospective Study
Run by Kate Farms Inc · NCT07231705 · Data updated 2026-11-12
This project will try two pea protein–based formulas to see if they support healthy growth and are well tolerated in children 12–17 months old who get most of their nutrition from formula.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Months to 17 Months |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Kate Farms Inc Industry-sponsored |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | March 13, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07231705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 12–17 months (corrected for prematurity) who rely on formula for at least 80% of energy intake and have a weight-for-length z score of ≥ -1.5, with caregivers able to follow the protocol and provide consent are ideal candidates.
✕Probably not a fit
Children with complex gastrointestinal anomalies, known malabsorption disorders (e.g., cystic fibrosis), significant hepatic or renal dysfunction, or inherited metabolic disorders, and children who do not depend on formula for most nutrition are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective cohort study enrolling 40 children aged 12–17 months who obtain at least 80% of their energy from formula, either orally or via tube feeding. Participants will receive one of two Kate Farms pea protein–based formulas for 24 weeks with regular clinic visits and monitoring. Outcomes include growth measures (weight, length, head circumference, MUAC and velocity), tolerance, body composition, key micronutrient levels, and gut microbiome changes. Recruitment and study visits occur through the Feeding Program, GI clinic, and Complex Care clinic at Nationwide Children's Hospital in Columbus, Ohio.
Why it matters
Potential benefit: If successful, the formulas could provide a well-tolerated plant-based option that supports healthy growth for formula-dependent young children.
How similar studies have gone: Pediatric data on pea protein–based enteral formulas are limited, with some adult and older-child studies showing acceptable tolerance but little robust growth data in toddlers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Children with known or suspected complex gastrointestinal anomalies or dysfunction, hepatic or renal dysfunction, or inherited metabolic disorders, suspected or diagnosed conditions associated with malabsorption (e.g. cystic fibrosis) (Note: For hepatic dysfunction, a conjugated bilirubin \>2.0 mg/dL and for renal dysfunction child should not meet any of the Pediatric Risk, Injury, Failure, Loss, End Stage Renal Disease (pRIFLE) criteria for renal disease (estimated creatinine clearance decreased by 25% by the Schwartz formula or urine output \<0.5 mL/kg per hour over the previous 8 or more hours) or has chronic medical renal disease. We will not obtain labs to exclude children. If children are noted to have liver disease or renal disease in their chart, we will look at their labs to ensure that they do not meet exclusion criteria). * 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.
Where it's running
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Nationwide Children's Hospital
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Praveen Goday, MD — Nationwide Children's Hospital
- Study coordinator: Taelor Shepherd
- Email: Taelor.Shepherd@nationwidechildrens.org
- Phone: (614) 722-4239
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.