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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorKate Farms Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: FormulaExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
24 weeks

Secondary outcomes

1

Weight-for-age

Z-scores for weight-for-age of between -1 and 0 up through 24 weeks relative to baseline.

Time frame
24 weeks
2

Length-for-age

Z scores for length-for-age of between -1 and 0 up through 24 weeks relative to baseline.

Time frame
24 weeks
3

Head circumference-for-age

Z-scores for head circumference-for-age of between -1 and 0 up through 24 weeks relative to baseline.

Time frame
24 weeks
4

Mid upper arm circumference (MUAC)-for-age

Z-scores for mid upper arm circumference (MUAC)-for-age of between -1 and 0 up through 24 weeks relative to baseline.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kate Farms Inc

Lead sponsor

Nationwide Children's Hospital

Collaborator