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.

Study Overview

• Status: Recruiting
• Conditions: Enteral Feeding
• Intervention / Treatment: Other: formulated liquid diet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Kuttenkeuler; Phone Number: 113 1-519-341-3367; Email: akuttenkeuler@nutrasource.ca
• Study Contact Backup: Name: Stephanie Recker; Phone Number: 109 1-877-557-7722; Email: srecker@nutrasource.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • Hospital for Sick Children
      • Contact: Jessie Hulst; Phone Number: 203565 (416) 813-7654; Email: jessie.hulst@sickkids.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enteral tube fed children; Children being fed an enteral formula with a feeding tube	Other: formulated liquid diet; will be fed exclusively the pediatric enteral study formula with a feeding tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional efficacy - energy	Percent of daily calorie nutritional goals met	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Daily adverse event reporting	14 days
Nutritional efficacy - protein	Percent of daily protein nutritional goals met	14 days
Frequency of nausea	Daily frequency of nausea for each participant	14 days
Frequency of vomiting	Daily frequency of vomiting for each participant	14 days
Bristol Stool Chart	Daily reporting of stool parameters using Bristol stool chart. Scale from 1-7. Type 1: Separate hard lumps (hard to pass) Type 2: Lumpy, hard, sausage-shaped Type 3: Sausage-shaped with cracks on the surface Type 4: Sausage-shaped or snake-like; smooth and soft Type 5: Soft blobs with clear-cut edges (easy to pass) Type 6: Fluffy pieces with ragged edges; mushy Type 7: Entirely liquid, watery, no solid pieces	14 days

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Jessie Hulst, MD, The Hospital for Sick Children; Study Chair: Cindy Steel, MSc, Nestle Health Science Canada; Study Director: Krys Araujo Torres, MD, Nestle Health Science USA

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: N02-20-01-T0004; 22.01.CA.HCN (Other Identifier: Sponsor)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No