Enteral Formula Tolerance of Standard Tube Feedings

This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.

Study Overview

• Status: Completed
• Conditions: Enteral Feeding
• Intervention / Treatment: Other: enteral formula

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • Bruyère Research Institute
• United States
  • Arkansas
    • Little Rock, Arkansas, United States
      • University of Arkansas
  • Tennessee
    • Nashville, Tennessee, United States
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with established enteral access receiving standard tube feeding formula

Description

Inclusion Criteria:

• ≥18 years of age
• Currently tolerating enteral feeding
• Has enteral access
• Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 21 days
• Having obtained his/her and/or his/her legal representative's informed consent.

Exclusion Criteria:

• Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
• Lack of enteral access
• Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other)
• Currently participating in another conflicting clinical study that would interfere with anticipated endpoints
• Judged to be at risk for poor compliance to the study protocol.
• Lack of informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
enterally fed adults; adult subjects with established enteral access receiving standard tube feeding formula	Other: enteral formula; standard tube feeding formulas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Daily percentage of caloric nutritional goal met	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Daily percentage of protein goal met	21 days
GI tolerance	21 days
Adverse events and serious adverse events	21 days

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 29, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 14.01.US.HCN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No