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OpenTrials
Completed

NCT Number: NCT05025267

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

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.

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Key information

Conditions

Enteral Feeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Food: Peptide-Based Enteral Formula

Other

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

Primary outcomes

  1. Calorie nutritional goals

    Time frame: 14 days

    Daily percentage of calorie nutritional goals met

Secondary outcomes

  1. Protein nutritional goals

    Time frame: 14 days

    Daily percentage of protein nutritional goals met

  2. Daily reports of gastrointestinal intolerance

    Time frame: 14 days

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

  3. Adverse events

    Time frame: 14 days

    Daily adverse event reporting

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 27, 2021
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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