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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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