Enteral Formula Tolerance of Standard Tube Feedings

NCT ID: NCT02312271

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-04-30

Brief Summary

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

Detailed Description

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Conditions

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Enteral Feeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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enterally fed adults

adult subjects with established enteral access receiving standard tube feeding formula

enteral formula

Intervention Type OTHER

standard tube feeding formulas

Interventions

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enteral formula

standard tube feeding formulas

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arkansas

Little Rock, Arkansas, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Bruyere Research Institute

Ottawa, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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14.01.US.HCN

Identifier Type: -

Identifier Source: org_study_id

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