Formula Dependent Children 1 to 2 Years of AgeNCT07231705
Growth and Tolerance of Plant-based Enteral Formulas in Children Ages 12-17 Months.
A study testing Kate Farms Standard 1.2 or Peptide 1.0 in people with Formula Dependent Children 1 to 2 Years of Age, run by Kate Farms Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 months
- Conditions the study is for
- Formula Dependent Children 1 to 2 Years of Age
- What is being tested?
- Kate Farms Standard 1.2 or Peptide 1.0
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Praveen Goday, MD, (614) 722-3450, praveen.goday@nationwidechildrens.org
Praveen Goday, MD
About this study
Official title: Growth and Enteral Tolerance of Plant-Based Enteral Formulas: A Prospective Study
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.
Read the 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
- Being tested
- Kate Farms Standard 1.2 or Peptide 1.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Kate Farms Standard 1.2 or Peptide 1.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 weeks
Secondary outcomes (13)
Weight-for-age
Z-scores for weight-for-age of between -1 and 0 up through 24 weeks relative to baseline.
Measured: 24 weeks
Length-for-age
Z scores for length-for-age of between -1 and 0 up through 24 weeks relative to baseline.
Measured: 24 weeks
Head circumference-for-age
Z-scores for head circumference-for-age of between -1 and 0 up through 24 weeks relative to baseline.
Measured: 24 weeks
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.
Measured: 24 weeks
Weight velocity
Average weight velocity in grams (g)
Measured: 24 weeks
Length velocity
Average length velocity in centimeters (cm)
Measured: 24 weeks
Tolerance - Spit up/vomiting
Percentage of feedings that results in spit up/vomiting based on 3-day food diaries
Measured: 24 weeks
Tolerance - Stool
Average number of stools per day
Measured: 24 weeks
Tolerance - Stool consistency
Average stool consistency using the Brussels Infant and Toddler Stool Scale
Measured: 24 weeks
Gastrointestinal (GI) and gastroesophageal (GER) reflux symptoms
GI and GER symptoms using the Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddler
Measured: 24 weeks
Body Composition
Body composition parameters using a bioelectrical impedance analysis
Measured: 24 weeks
Gut Microbiome
Stool microbiome analysis
Measured: 24 weeks
Micronutrient analysis
Iron and zinc nutriture
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start13 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Formula Dependent Children 1 to 2 Years of AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kate Farms Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Praveen Goday, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231705
- Sponsor's protocol ID
- Nationwide2025
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Enteral Tolerance of Plant-Based Enteral Formulas: A Prospective Study
- ClinicalTrials.gov ID
- NCT07231705
- Acronym / sponsor ID
- Nationwide2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kate Farms IncIndustry (pharma, biotech, devices)
- Collaborators
- Nationwide Children's Hospital
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formula | Experimental | Dietary Supplement: Kate Farms Standard 1.2 or Peptide 1.0The 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). |
Who may qualify
- Ages
- 12 to 17 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kate Farms Standard 1.2 or Peptide 1.0Kate 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. | Dietary supplement | Formula |
Primary outcome
Weight-for-length z-score
Time frame: 24 weeks
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)
13 secondary outcomes
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
Micronutrient analysis
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Praveen Goday, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kate Farms Standard 1.2 or Peptide 1.0 in people with Formula Dependent Children 1 to 2 Years of Age, run by Kate Farms Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taelor Shepherd ((614) 722-4239, Taelor.Shepherd@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-for-length z-score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.