Ability to Meet Enteral Nutritional Needs with a Peptide-based, High Protein Formula
Not Applicable
Completed
- Conditions
- Enteral Feeding
- Registration Number
- NCT05025267
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief Summary
This is a prospective, open-label single-arm observational clinical trial to assess enteral feeding nutrition goals with a peptide-based, high protein enteral formula.
- Detailed Description
This is a prospective, observational study to assess the ability to meet enteral nutrition goals and tolerance of a peptide-based, high protein tube feeding product in adult, tube-fed patients living in the community setting. In addition, the study will explore metabolic and inflammatory markers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Adults with established enteral access
- Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs
- Signed informed consent
Exclusion Criteria
- Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
- Any condition that would contraindicate use of the study product
- Patients with active colitis, radiation enteritis, SBS, undergoing active cancer treatment
- Judged to be at risk for poor compliance to the study protocol
- Participating in a conflicting clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Calorie nutritional goals 14 days Daily percentage of calorie nutritional goals met
- Secondary Outcome Measures
Name Time Method Daily reports of gastrointestinal intolerance 14 days Daily occurrence of nausea, stool frequency, stool consistency, and/or vomiting)
Adverse events 14 days Daily adverse event reporting
Protein nutritional goals 14 days Daily percentage of protein nutritional goals met
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States