Enteral Formula Tolerance of Standard Tube Feedings | NCT02312271

Studies
Enteral Formula Tolerance of Standard Tube Feedings

NCT02312271

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

May 31, 2017Actual

Enrollment

102Actual

Phase

Not provided

Conditions

Enteral Feeding

Interventions

enteral formula

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Mar 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Dec 5, 2014

First Submission Date that Met QC Criteria

Dec 5, 2014

First Posted Date

Dec 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2017

Last Update Posted Date

May 31, 2017Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
enterally fed adults		adult subjects with established enteral access receiving standard tube feeding formula	Other: enteral formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
enteral formula	Other	standard tube feeding formulas	enterally fed adults

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with established enteral access receiving standard tube feeding formula

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas		Little Rock	Arkansas		United States
Vanderbilt University