Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

Enteral Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838495
• Other study ID #: N02-20-01-T0004
• Secondary ID: 22.01.CA.HCN
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Société des Produits Nestlé (SPN)
• Contact: Adam Kuttenkeuler
• Phone: 1-519-341-3367
• Email: akuttenkeuler[@]nutrasource.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enteral Feeding

Intervention

Other:
• formulated liquid diet
will be fed exclusively the pediatric enteral study formula with a feeding tube

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional efficacy - energy	Percent of daily calorie nutritional goals met	14 days
Secondary	Nutritional efficacy - protein	Percent of daily protein nutritional goals met	14 days
Secondary	Frequency of nausea	Daily frequency of nausea for each participant	14 days
Secondary	Frequency of vomiting	Daily frequency of vomiting for each participant	14 days
Secondary	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
Secondary	Adverse events	Daily adverse event reporting	14 days