A Prospective, Observational Study to Evaluate the Use of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition

Abbott Nutrition9 sites in 1 country17 target enrollmentJune 8, 2018

ConditionsMalnutrition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Malnutrition
Sponsor: Abbott Nutrition
Enrollment: 17
Locations: 9
Primary Endpoint: Tube Feed Product Compliance
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 8, 2018

End Date

February 7, 2019

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Malnourished or at risk for malnutrition based on the Malnutrition Universal Tool (MUST) score ≥
•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.