Recruiting

Pediatric Standard & Pediatric Peptide

Sponsor:

Kate Farms Inc

Code:

NCT07231705

Conditions

Formula Dependent Children 1 to 2 Years of Age

Eligibility Criteria

Sex: All

Age: 1

Healthy Volunteers: Not accepted

Interventions

Kate Farms Standard 1.2 or Peptide 1.0

Study Details

Brief 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.

Conditions

Formula Dependent Children 1 to 2 Years of Age

Study ID

NCT07231705

Start date

Mar 13, 2026

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Formula

The study intervention will be 2 pea protein-based formulas Kate Farms Pediatric Standard formula 1.2 (KF-PS) and Kate Farms Standard Pediatric Peptide Formula 1.0 (KF-PP).

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.

Primary outcome measure

  • Weight-for-length z-score [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Taelor Shepherd

(614) 722-4239Taelor.Shepherd@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Praveen Goday, MD

(614) 722-3450praveen.goday@nationwidechildrens.org

Principal Investigator:

Praveen Goday, MD

More Information

Sponsor

Kate Farms Inc

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Kate Farms Inc on 2026-04-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.