Ability to Meet Enteral Nutritional Needs with a Peptide-based, High Protein Formula

Nestlé

Status: Completed

Conditions: Enteral Feeding

Treatments: Other: Medical Food: Peptide-Based Enteral Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT05025267

19.01.CA.HCN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Enteral Tube-fed Adults

Other group

Description:

Adults being fed an enteral formula with a feeding tube

Treatment:

Other: Medical Food: Peptide-Based Enteral Formula