Growth and Tolerance of Plant-based Enteral Formulas in Children Ages 12-17 Months.

Conditions

• Formula Dependent Children 1 to 2 Years of Age

Eligibility Criteria

Sex

ALL

Age

12 Months - 17 Months

Healthy Volunteers

Not accepted

Interventions

• Kate Farms Standard 1.2 or Peptide 1.0 — DIETARY_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.

Study Details

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.

Key Dates

Start date

Mar 13, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Mar 31, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

• Taelor Shepherd
  (614) 722-4239
  [email protected]

Locations (1)

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