NCT05025267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

August 23, 2021

Last Update Submit

November 4, 2024

Conditions

Enteral Feeding

Outcome Measures

Primary Outcomes (1)

  • Calorie nutritional goals

    Daily percentage of calorie nutritional goals met

    14 days

Secondary Outcomes (3)

  • Protein nutritional goals

    14 days

  • Daily reports of gastrointestinal intolerance

    14 days

  • Adverse events

    14 days

Study Arms (1)

Enteral Tube-fed Adults

OTHER

Adults being fed an enteral formula with a feeding tube

Other: Medical Food: Peptide-Based Enteral Formula

Interventions

Medical Food: Peptide-Based Enteral FormulaOTHER

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

Enteral Tube-fed Adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with established enteral access
  • Anticipated to require enteral nutrition to provide 90% or more of their nutritional needs
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Krysmaru Araujo Torres, MD

    Nestle Health Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Prospective, single-arm, non-randomized, open-label observational study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 27, 2021

Study Start

January 31, 2022

Primary Completion

April 15, 2023

Study Completion

May 31, 2023

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)