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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05025267

Enrollment

Registered

2021-08-27

Start date

2022-01-31

Completion date

2023-05-31

Last updated

2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding

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.

Interventions

OTHERMedical Food: Peptide-Based Enteral Formula

Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Prospective, single-arm, non-randomized, open-label observational study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Calorie nutritional goals	14 days	Daily percentage of calorie nutritional goals met

Secondary

Measure	Time frame	Description
Protein nutritional goals	14 days	Daily percentage of protein nutritional goals met
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026