NCT07231705

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

March 13, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

November 13, 2025

Last Update Submit

April 13, 2026

Conditions

Formula Dependent Children 1 to 2 Years of Age

Outcome Measures

Primary Outcomes (1)

  • Weight-for-length z-score

    To sustain/improve to a weight-for-length z-score of between -1 and 0 up through 24 weeks, in children who are predominantly receiving nutrition via formula (either orally or via tube feeding)

    24 weeks

Secondary Outcomes (13)

  • Weight-for-age

    24 weeks

  • Length-for-age

    24 weeks

  • Head circumference-for-age

    24 weeks

  • Mid upper arm circumference (MUAC)-for-age

    24 weeks

  • Weight velocity

    24 weeks

  • +8 more secondary outcomes

Study Arms (1)

Formula

EXPERIMENTAL

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).

Dietary Supplement: Kate Farms Standard 1.2 or Peptide 1.0

Interventions

Kate Farms Standard 1.2 or Peptide 1.0DIETARY_SUPPLEMENT

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.

Formula

Eligibility Criteria

Age12 Months - 17 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Study Officials

  • Praveen Goday, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taelor Shepherd

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

March 13, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)