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Clinical Trials/NCT05838495
NCT05838495
Completed
N/A

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

Société des Produits Nestlé (SPN)1 site in 1 country27 target enrollmentJune 1, 2023
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ConditionsEnteral Feeding

Overview

Phase
N/A
Intervention
Not specified
Conditions
Enteral Feeding
Sponsor
Société des Produits Nestlé (SPN)
Enrollment
27
Locations
1
Primary Endpoint
Nutritional efficacy - energy
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
July 6, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Société des Produits Nestlé (SPN)
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Nutritional efficacy - energy

Time Frame: 14 days

Percent of daily calorie nutritional goals met

Secondary Outcomes

  • Nutritional efficacy - protein(14 days)
  • Bristol Stool Chart(14 days)
  • Adverse events(14 days)
  • Frequency of nausea(14 days)
  • Frequency of vomiting(14 days)

Study Sites (1)

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