ReliZORB for Multiple Organ Failure

Recruiting at 1 trial location

Overseen By Laura E Madarasz, MS, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inova Health Care Services

Must not be taking: Pancreatic hormones, Parenteral nutrition

Disqualifiers: Pregnancy, Prisoners, Cancer treatment, others

Compensation: Varies

Number of Visits: 2

Duration: 5 days

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether RELiZORB™, a cartridge containing digestive enzymes, can help individuals with multiple organ failure absorb nutrients more effectively from tube feedings. RELiZORB™ has already received approval for some patients with tube feedings, but this trial specifically tests its use for those with multiple organ failure. Participants will receive either the RELiZORB™ cartridge or a placebo (an inactive, harmless cartridge) to compare outcomes. Suitable candidates for this trial include those experiencing multiple organ failure who are starting or have recently started tube feeding. As an unphased trial, this study provides a unique opportunity to enhance understanding of how RELiZORB™ may benefit patients with multiple organ failure.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using pancreatic hormone stimulants or inhibitors, you may not be eligible to participate.

What prior data suggests that this device is safe for use in patients with multiple organ failure?

Research has shown that RELiZORB™ is safe and well-tolerated. Studies have found that using RELiZORB™ increases fatty acids in the blood, indicating improved fat absorption. Importantly, these studies reported no major safety issues. The FDA has approved RELiZORB™ for patients aged 5 and older who need help digesting tube feedings, which adds confidence in its safety for humans. While this study focuses on patients with multiple organ failure, RELiZORB™ has demonstrated safety in other situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

ReliZORB is unique because it offers a novel way to deliver essential nutrients to patients with multiple organ failure. Unlike traditional treatments that rely on standard enteral feeding, ReliZORB uses a specialized cartridge that connects directly to feeding tubes. This allows for more efficient digestion and absorption of fats, which can be crucial for patients who are struggling with nutrient absorption due to organ failure. Researchers are excited about ReliZORB's potential to improve nutrient delivery and overall patient outcomes in a way that standard feeding methods can't match.

What evidence suggests that RELiZORB™ is effective for improving nutrition tolerance in patients with multiple organ failure?

Studies have shown that RELiZORB improves fat absorption in people with digestion issues due to pancreatic problems. This device uses a special enzyme called lipase to break down fats, making them easier for the body to use. Research indicates that many patients who used RELiZORB had better body mass index (BMI) scores after 12 months. It is safe and well tolerated, causing few side effects. In this trial, some participants will receive RELiZORB to explore its potential in helping people with multiple organ failure meet their nutritional needs, while others will receive a placebo for comparison. ^{1 6 7 8 9}

Who Is on the Research Team?

George Kasotakis, MD MPH

Principal Investigator

Inova Fairfax Medical Campus

Are You a Good Fit for This Trial?

This trial is for critically ill adults with multi-organ failure who have been admitted to the ICU within the last 72 hours and haven't started enteral nutrition. It excludes pregnant women, prisoners, those with certain infections or shock due to heart problems, recent cancer treatment recipients, and patients expected to pass away within 72 hours.

Inclusion Criteria

I need tube feeding but haven't started it yet.

I need medication to support my heart and a machine to help me breathe.

My legal representative has consented for me as I am unable to do so myself.

Exclusion Criteria

I have used medication that affects pancreatic hormone levels around the time I was admitted to the hospital.

I have a gastrointestinal infection causing diarrhea.

Pregnant women and prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive enteral nutrition through ReliZORB™ or placebo cartridges for 5 days

5 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• ReliZORB

Trial Overview The study tests if ReliZORB™ improves feeding tolerance in critically ill patients. ReliZORB™ is a digestive enzyme cartridge that helps break down fats during tube feedings. Participants will either receive ReliZORB™ or a placebo alongside their standard care.

How Is the Trial Designed?

Group I: RELiZORB Experimental Treatment 1 Intervention

RELiZORB™ cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes.

Group II: Placebo Placebo Group 1 Intervention

Placebo cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Alcresta Therapeutics, Inc.

Industry Sponsor

Trials

6

Recruited

240+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05710315

Evaluating the Utility of RELiZORB™ for Treating Feeding ... The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition ...

2. alcresta.com alcresta.com/news/alcresta-therapeutics-announces-enrollment-of-first-patient-in-clinical-trial-evaluating-use-of-relizorb-in-critical-care-patients-at-inova-fairfax-medical-campus/

Alcresta Therapeutics Announces Enrollment of First ... Studies have demonstrated that RELiZORB is safe, well tolerated, and effective in improving fat absorption for patients with pancreatic ...

3. prnewswire.com prnewswire.com/news-releases/alcresta-therapeutics-announces-enrollment-of-first-patient-in-clinical-trial-evaluating-use-of-relizorb-in-critical-care-patients-at-inova-fairfax-medical-campus-302481743.html

Alcresta Therapeutics Announces Enrollment of First ... Studies have demonstrated that RELiZORB is safe, well tolerated, and effective in improving fat absorption for patients with pancreatic ...

4. trialx.com trialx.com/clinical-trials/listings/298280/evaluating-the-utility-of-relizorbtm-for-treating-feeding-intolerance-in-critically-ill-adults-with-multi-organ-failure/?&radius=50

Evaluating the Utility of RELiZORB™ for Treating Feeding ... Overview. The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1097%2FMPG.0000000000002984

Evaluation of the Effectiveness of In‐line Immobilized ... Fifty percentage of patients achieved ≥50th percentile for body mass index at 12 months, compared with 37.1% at baseline. Immobilized lipase ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6155360/

Absorption and Safety With Sustained Use of RELiZORB ... Conclusions: RELiZORB use was found to be safe, well tolerated, and resulted in increased levels of FAs in RBCs and plasma. This is the first prospective study ...

7. withpower.com withpower.com/trial/phase-multiple-organ-failure-1-2023-81183

ReliZORB for Multiple Organ Failure The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition ...

8. alcresta.com alcresta.com/clinical/

Clinical Studies Results from this study demonstrated that RELiZORB, when used per the intended use, was safe and well-tolerated and reduced signs of gastrointestinal ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02750501

Absorption and Safety With Sustained Use of RELiZORB ... Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat ...