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

Official title

Growth and Enteral Tolerance of Plant-Based Enteral Formulas: A Prospective Study

Overview

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.

Detailed description

This is a prospective cohort study. Forty children ages 12-17 months who rely on formula for at least 80% of their nutritional needs (by mouth of tube feeding) are expected to continue this dependence for the next 6 months will be recruited. Children will be recruited from the Feeding Program, GI clinic and Complex Care clinic at Nationwide Children's Hospital in Columbus, Ohio. The study will be introduced to the patient by the provider during a routine clinic visit. Parent consent will be obtained from one of the research investigators during the clinic visit.

The objectives are to study the effect of these formulas on the functions of the body (AND NOT to evaluate its role in any disease state) in the form of growth and nutrition status.

\- 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)

Secondary study objectives:

* To sustain other anthropometric measurements * To assess tolerance * To assess changes in body composition and gut microbiome * To assess changes in key micronutrients.

To sustain the following z scores up through 24 weeks relative to baseline:

* Weight-for-age * Length-for-age * Head circumference-for-age * Mid upper arm circumference (MUAC)-for-age * Weight velocity * Length velocity o When ex-preterm infants are recruited, all of these measures will be corrected for gestational age.

Tolerance: Composite measure of tolerance using 3-day diaries:

* Percentage of feedings that result in spit up/vomiting * Average number of stools/day * Average stool consistency score using the Brussels Infant and Toddler stool scale * Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infant and Toddlers

Body composition: Bioelectrical impedance analysis Gut microbiome: Stool microbiome analysis Micronutrient analysis: Iron and zinc nutriture

Interventions

• Dietary supplement 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 measures

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

Secondary outcome measures (12)

• Weight-for-age [Time frame: 24 weeks]
• Length-for-age [Time frame: 24 weeks]
• Head circumference-for-age [Time frame: 24 weeks]
• Mid upper arm circumference (MUAC)-for-age [Time frame: 24 weeks]
• Weight velocity [Time frame: 24 weeks]
• Length velocity [Time frame: 24 weeks]
• Tolerance - Spit up/vomiting [Time frame: 24 weeks]
• Tolerance - Stool [Time frame: 24 weeks]
• Tolerance - Stool consistency [Time frame: 24 weeks]
• Gastrointestinal (GI) and gastroesophageal (GER) reflux symptoms [Time frame: 24 weeks]
• Body Composition [Time frame: 24 weeks]
• Gut Microbiome [Time frame: 24 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Nationwide Children's Hospital — Columbus

Identifiers

NCT: NCT07231705 · Nationwide2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗