Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

A Single-center, Open-label Study on the Nutritional Adequacy, Tolerability, and Safety of a Hypercaloric, Plant-based, Real Food Ingredient Formula for Tube Fed Pediatric Patients

To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.

The purpose of this study is to assess the efficacy (ability to meet prescribed calorie and protein needs), tolerance, and safety of a pediatric enteral formula (i.e., the study product) in participants aged 1-13 years for 14 days of use.

Inclusion Criteria:

• Medically stable, enterally tube-fed children
• Aged 1 to 13 years (inclusive) at the time of screening.
• Currently tolerating enteral feeding and should be appropriate for study formula
• Requires enteral tube feeding to provide 90% or more of their nutritional needs
• signed informed consent

Exclusion Criteria:

• Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
• Currently using or has previously used the study product
• Any medical condition or contraindicated medications that would contraindicate use of the study product
• Any illness within ~5-7 days of screening and/or baseline lasting >48 hours and assessed by the PI to have affected nutritional intake on a case-by-case basis.
• Participation in another interventional clinical study
• Any condition or abnormality that, in the opinion of the PI, would compromise the safety of the participant or the quality of the study data.