Evaluation of a High Calorie, High Protein Tube Feeding P... | NCT03459001

Studies
Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition

NCT03459001

Sponsor

Abbott Nutrition

Status

Completed

Last Update Posted

Apr 19, 2019Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Malnutrition

Interventions

Tube Feeding Product

Countries

Spain

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

Apr 2019

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

Jun 8, 2018Actual

Primary Completion Date

Feb 7, 2019Actual

Completion Date

Feb 7, 2019Actual

First Submitted Date

Mar 2, 2018

First Submission Date that Met QC Criteria

Mar 2, 2018

First Posted Date

Mar 8, 2018Actual

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

Apr 18, 2019

Last Update Posted Date

Apr 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective, observational study is designed to observe the use of a high calorie, high protein tube feed product in adults that are malnourished or at risk of malnutrition, as assessed by a clinician, and have been placed on a nutritional care plan which includes a tube feeding formula, per standard of care.

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

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tube Fed Malnourished Outpatients		Outpatients that are malnourished or at risk of malnutrition and have been placed on a nutritional care plan, which includes a complete tube feeding formula as sole source nutrition	Other: Tube Feeding Product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tube Feeding Product	Other	a high calorie, high protein tube feed product consumed sole source per their physician's recommendation and per standard of care	Tube Fed Malnourished Outpatients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tube Feed Product Compliance	Average Daily Intake and Proportion of Days Compliant	Day 1 to Day 20

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	Non serious AE and SAE collection	Day 0 to Day 20
Body Mass Index	Weight, Height	Day 0 to Day 20

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Malnourished or at risk for malnutrition based on the Malnutrition Universal Tool (MUST) score ≥ 2.
Under the care of a health care professional for malnutrition or at risk of malnutrition and has been prescribed the study formula.
Requires and agrees to be tube fed the enteral feeding product for at least 16 consecutive days as their sole-source of nutritional intake.
Free living in the community or is residing in a nursing home.
Conforms to the requirements set forth on the study product label.

Exclusion Criteria:

Currently taking or has taken antibiotics within 2 weeks prior to enrollment.
Consuming food PO.
Current active cancer and the study physician determines that the subject is not suitable for the study.
History of diabetes mellitus as evidenced by taking anti-hyperglycemic medications or by self-reported dietary modification for control of diabetes mellitus.
Renal or liver failure.
Pregnant as demonstrated by self-report.
Severe auto immune disease (per physician's discretion) and is on immuno-modulating therapy.
History of allergy to any of the ingredients in the study product.
Active Human Immunodeficiency Virus (HIV).
Known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption and does not have a caregiver who can assist them with adherence to the study protocol.
Condition that is contraindicated to tube feeding the study product.
Taking part in a non-approved clinical trial.

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

Outpatients ≥ 18 years of age that are malnourished or at risk of malnutrition and have been placed on a nutritional care plan, which includes a complete tube feeding formula as sole source nutrition will be recruited.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Residencia Plata y Castañar		Madrid		28021	Spain
Residencia Albertia Moratalaz

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases