Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT07231705
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Growth and Tolerance of Plant-based Enteral Formulas in Children Ages 12-17 Months.
Sponsor:
Kate Farms Inc
Organization:
Study Overview
Official Title:
Growth and Enteral Tolerance of Plant-Based Enteral Formulas: A Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: