RELiZORB for Acute Pancreatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Relizorb, an enzyme that aids in fat digestion, can enhance the nutritional intake of individuals with moderate to severe pancreatitis during tube feeding. The primary question is whether Relizorb can deliver more nutrition than usual to those who struggle with tube feeding. Participants will receive standard monitoring as Relizorb integrates into their feeding routine. The trial seeks adults admitted to the Surgical Intensive Care Unit with moderate to severe acute pancreatitis who cannot tolerate most of their tube feeding. As a Phase 4 trial, Relizorb has already received FDA approval and demonstrated effectiveness, and this research aims to understand how it can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What is the safety track record for this treatment?
Research has shown that RELiZORB is generally safe and well-tolerated. Studies have found that RELiZORB improves fat absorption in people with conditions like cystic fibrosis and pancreatic insufficiency. In these studies, RELiZORB proved safe, with participants experiencing few side effects. The treatment breaks down fats in tube feeding, aiding better digestion.
Additionally, the FDA has approved RELiZORB for similar conditions, indicating a strong safety record. While ongoing research explores its benefits for patients with pancreatitis, current evidence supports RELiZORB as a safe option for enhancing nutrition delivery in those who need it.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for acute pancreatitis, which typically involve pain management and nutritional support without directly enhancing digestion, RELiZORB introduces a novel approach by using a lipase-containing cartridge. This cartridge is placed in-line with enteral nutrition tubing to pre-digest fats before they enter the patient's intestines. Researchers are excited about RELiZORB because it helps patients who struggle to tolerate sufficient nutrition, potentially improving their overall energy intake and recovery process.
What evidence suggests that Relizorb might be an effective treatment for pancreatitis?
Research has shown that RELiZORB helps people using feeding tubes absorb fats more effectively. This is crucial for patients with cystic fibrosis, as it aids in weight gain and growth by enhancing fat absorption. RELiZORB also benefits individuals whose pancreas doesn't produce enough digestive enzymes, a condition known as exocrine pancreatic insufficiency. Although earlier studies focused on cystic fibrosis, the benefits extend to those with pancreatitis, as both conditions hinder fat digestion. In this trial, participants with moderate to severe pancreatitis will receive RELiZORB to support fat digestion as part of their enteral nutrition.15678
Who Is on the Research Team?
Laura Hansen, MD
Principal Investigator
Northwell Health
Rafael Barrera, MD
Principal Investigator
Northwell Health
Are You a Good Fit for This Trial?
This trial is for adults (18+) in the ICU with moderate to severe acute pancreatitis who are having trouble getting enough nutrition from tube feeding. Participants must be patients at Northwell Health hospitals and unable to tolerate most of their recommended tube feeds.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Relizorb to improve tolerance of tube feeds
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RELiZORB
Trial Overview
The study tests whether adding RELiZORB, a cartridge containing fat-digesting enzymes, helps adults with pancreatitis better absorb nutrition from tube feeds. Patients will be closely monitored while using this device.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients with moderate to severe pancreatitis who are not tolerating sufficient enteral nutrition will have a lipase-containing cartridge (Relizorb) placed in-line with their enteral nutrition tubing, to digest the fat in the formula prior to entering the patient's intestine.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
Alcresta Therapeutics, Inc.
Industry Sponsor
Citations
Evaluating the Efficacy of RELiZORB in Managing Exocrine ...
This study aims to determine whether RELiZORB is effective for individuals requiring feeding tube support after pancreatitis.
Evaluating the Efficacy of RELiZORB in Managing Exocrine ...
This research aims to improve the management of exocrine pancreatic insufficiency (EPI), a condition that can develop after pancreatitis, ...
3.
southcarolinablues.com
southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/enteral-feeding-in-line-cartridge-eficimmobilized-lipase-cartridgerelizorb/Enteral Feeding In-Line Cartridge (EFIC™)/Immobilized ...
Even with Relizorb's de novo FDA approval, there is insufficient evidence to support the safety, effectiveness, and impact on health outcomes resulting from the ...
Alcresta Therapeutics Announces Enrollment of First ...
Studies have demonstrated that RELiZORB is safe, well-tolerated, and effective in improving fat absorption for patients with cystic fibrosis. “ ...
Optimizing Clinical and Cost Outcomes for Patients on Enteral ...
The RELiZORB immobilized lipase enzyme cartridge was developed to help maximize the effectiveness EN for these patients and other ...
RELiZORB® (iMMOBILIZED LIPASE) CARTRIDGE STUDY ...
Use of RELiZORB demonstrated long-term clinical growth improvements in people with pancreatic insufficiency due to CF4. This study was a retrospective ...
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 ...
Absorption and Safety With Sustained Use of RELiZORB ...
RELiZORB use was found to be safe, well tolerated, and resulted in increased levels of FAs in RBCs and plasma.
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