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

Sponsor
Nestlé (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05025267
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
9
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Medical Food: Peptide-Based Enteral Formula
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, single-arm, non-randomized, open-label observational studyProspective, single-arm, non-randomized, open-label observational study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Prospective Study Of Ability To Meet Nutritional Needs With A Peptide-based, High Protein Enteral Formula
Actual Study Start Date :
Jan 31, 2022
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Enteral Tube-fed Adults

Adults being fed an enteral formula with a feeding tube

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

Outcome Measures

Primary Outcome Measures

  1. Calorie nutritional goals [14 days]

    Daily percentage of calorie nutritional goals met

Secondary Outcome Measures

  1. Protein nutritional goals [14 days]

    Daily percentage of protein nutritional goals met

  2. Daily reports of gastrointestinal intolerance [14 days]

    Daily occurrence of nausea, stool frequency, stool consistency, and/or vomiting)

  3. Adverse events [14 days]

    Daily adverse event reporting

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Nestlé

Investigators

  • Study Director: Krysmaru Araujo Torres, MD, Nestle Health Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nestlé
ClinicalTrials.gov Identifier:
NCT05025267
Other Study ID Numbers:
  • 19.01.CA.HCN
First Posted:
Aug 27, 2021
Last Update Posted:
Mar 7, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 7, 2022