Status:
COMPLETED
Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition
Lead Sponsor:
Abbott Nutrition
Conditions:
Malnutrition
Eligibility:
All Genders
18+ years
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 clin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 7 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03459001
Start Date
June 8 2018
End Date
February 7 2019
Last Update
April 19 2019
Active Locations (9)
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1
Residencia Plata y Castañar
Madrid, Spain, 28021
2
Residencia Albertia Moratalaz
Madrid, Spain, 28030
3
Residencia Valle de la Oliva
Madrid, Spain, 28220
4
Hospital Clinico de Valencia
Valencia, Spain, 46010