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RELiZORB™ for Feeding Intolerance in Critically Ill Adults

This study is looking at whether a device called RELiZORB™ can help critically ill adults with Multi-Organ Failure (when several organs in the body are not working well) better tolerate their tube feedings. RELiZORB™ is a cartridge that connects to tube feedings and contains digestive enzymes to help break down fats, making them easier for your body to absorb. The study aims to see if using RELiZORB™ for 5 days helps patients meet their nutrition goals. You might be able to join if you are 18-89 years old, have Multi-Organ Failure, and need tube feeding. The study is currently unclear on its recruitment status.

Study design
This is a double-blind, placebo-controlled study, meaning neither you nor your doctors will know if you are receiving RELiZORB™ or a placebo (an inactive cartridge). About 32 adult patients will participate.
What's involved
If you join, you will receive tube feedings through either a RELiZORB™ or placebo cartridge for 5 days. Up to 6 cartridges may be used per day, depending on your feeding volume.
Compensation
Not stated in the trial record.
Follow-up
You will be studied for 5 days, which is considered the end of the study. After this, you will return to your usual nutritional support.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05710315

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

Active, Not Recruiting
NAAges 18–89InterventionalDiagnostic
Inova Health Care Services
~32 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:RELiZORB™Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five Days
Measured over Duration of intervention (5 days)

Conditions

Multi Organ Failure
Exocrine Pancreatic Insufficiency

Explore related trials

Multiple Organ Failure

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • George Kasotakis, MD MPH · PRINCIPAL_INVESTIGATOR · Inova Fairfax Medical Campus

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female patients aged 18 - 89 years of age.
Patients who have Multi-Organ Failure (MOF) (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission).
Patients who have not yet been initiated on enteral nutrition, yet enteral nutritional support is needed, or patients who have been initiated on enteral nutrition within the previous 48 hours. Enteral nutrition support defined as support planned to be given via any route connected to the gastrointestinal system (i.e., the enteral route). This includes tube feeding using nasogastric, nasoduodenal, gastrostomy, jejunostomy tubes, or similar.
Patients who lack the capacity to consent for themselves may be included upon receiving consent from their legally authorized representatives.

Exclusion

Pregnant women and prisoners.
Hypotension is attributed to suspected or confirmed cardiogenic shock.
Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition.
Sepsis suspected or confirmed due to an abdominal source and enteral nutrition is contraindicated.
C. Difficile or other gastrointestinal infection that may manifest with diarrhea.
Use of pancreatic hormone stimulant or inhibitor (e.g. octreotide, pancreatic enzyme supplements) during or immediately prior to hospital admission.
Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition.

What this trial measures

  • Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five DaysDuration of intervention (5 days)

    Efficacy will be assessed by the total calories administered, expressed as the percentage of goal nutrition calories achieved daily, compared between the two groups over the five-day study period