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

Enteral Feeding Clinical Trial

Official title:

Prospective Study Of Ability To Meet Nutritional Needs With A Peptide-based, High Protein Enteral Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025267
• Other study ID #: 19.01.CA.HCN
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 31, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enteral Feeding

Intervention

Other:
• Medical Food: Peptide-Based Enteral Formula
Will be fed exclusively the study peptide-based, high protein enteral formula via a feeding tube

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calorie nutritional goals	Daily percentage of calorie nutritional goals met	14 days
Secondary	Protein nutritional goals	Daily percentage of protein nutritional goals met	14 days
Secondary	Daily reports of gastrointestinal intolerance	Daily occurrence of nausea, stool frequency, stool consistency, and/or vomiting)	14 days
Secondary	Adverse events	Daily adverse event reporting	14 days