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Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure

NCT05710315 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-04

No results posted yet for this study

Summary

The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. It promotes breaking down fat and helps the body absorb it. The device connects with tube feedings to help the body with digestion.

RELiZORB™ is approved by the U.S. Food and Drug Administration (FDA) for use with tube feedings in patients 5 years of age or older. While the use of RELiZORB™ in this study is consistent with the FDA approval, the use of RELiZORB™ in patients with multi organ failure is not in the current standard of care practice at Inova Health Care facilities.

Conditions

  • Multi Organ Failure
  • Exocrine Pancreatic Insufficiency

Interventions

DEVICE

RELiZORB™

RELiZORB cartridges will be used with routine enteral feedings for 5 days for randomized participants

OTHER

Placebo

Placebo cartridges will be used with routine enteral feedings for 5 days for randomized participants

Sponsors & Collaborators

  • Alcresta Therapeutics, Inc.

    collaborator INDUSTRY

  • Inova Health Care Services

    lead OTHER

Principal Investigators

  • George Kasotakis, MD MPH · Inova Fairfax Medical Campus

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05710315 on ClinicalTrials.gov