Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis

Open-label, Multicenter, Phase IV, Study Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis

The goal of this study is to learn if Relizorb, a fat-digesting enzyme, can improve tolerance of tube feeds in adult patients with moderate to severe pancreatitis. The main question it aims to answer is:

Does Relizorb allow more nutrition to be delivered to participants than they received without it?

Participants will be observed with standard, universal monitoring after adding Relizorb to their nutrition regimen.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acute Pancreatitis (AP); Enhancing Enteral Nutrition Tolerance
• Intervention / Treatment: Device: RELiZORB digestive enzyme (immobilized lipase) cartridge

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bay Shore, New York, United States, 11706
      • South Shore University Hospital
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • Manhattan, New York, United States, 10075
      • Lenox Hill Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female aged 18 + years of age
• Admission to the Surgical Intensive Care Unit in the Northwell Health hospital system
• Moderate to severe acute pancreatitis based on Atlanta criteria
• Inability to tolerate ≥75% of goal EN (25 kcal/kg/d)

Exclusion Criteria:

• Moribund patients expected to expire within 120 hours
• Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition
• Diagnosis or evidence of C. Difficile or other gastrointestinal infection that may manifest with diarrhea
• Pre-existing constipation defined as laxative or stool softener use prior to admission to the hospital
• Patients receiving cancer-related treatment in the last 3 months
• History of cystic fibrosis
• Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relizorb 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.	Device: RELiZORB digestive enzyme (immobilized lipase) cartridge; An in-line digestive enzyme cartridge designed for hydrolyzing lipids within enteral nutrition will be used to improve tube feed tolerance in patients with moderate to severe pancreatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of goal nutrition delivered at 72 hours	Change from baseline in percentage of goal enteral nutrition (kcal/kg/day) received 3 days (72 hours) following initiation of RELiZORB. Baseline is considered the 24 hours prior to RELiZORB start.	From enrollment to the end of treatment at 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of goal nutrition delivered at 24 hours	Change from baseline in goal percentage of enteral nutrition (kcal/kg/day) received 1 day (24 hours) following initiation of RELiZORB.	From enrollment to 24 hours after starting RELiZORB
Responders at 72 hours	Percent of patients considered responders defined as receiving ≥80% of their daily enteral nutritional goal 3 days (72 hours) following initiation of RELiZORB use.	From enrollment to end of treatment at 72 hours
Responders at 24 hours	Percent of patients considered responders defined as receiving ≥80% of their daily enteral nutritional goal 1 day (24 hours) following initiation of RELiZORB use.	From enrollment to 24 hours after starting treatment
Vomiting	Change in the number of vomiting episodes per 24 hour period from baseline to 24 and 72 hours following initiation of RELiZORB use	From enrollment to completion of treatment at 72 hours
Stool volume	Change in stool volume per 24 hour period from baseline to 24 and 72 hours following initiation of RELiZORB use (if rectal tube is in place)	From enrollment to completion of treatment at 72 hours
Bowel movements	Change in number of bowel movement episodes in 24 hours from baseline to 24 hours and 72 hours after RELiZORB (if no rectal tube)	From enrollment to completion of treatment at 72 hours
Feeding Interruptions	Number of unplanned interruptions in tube feeding from baseline to 24 hours and 72 hours following initiation of RELiZORB use	From enrollment to completion of treatment at 72 hours

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Alcresta Therapeutics, Inc.
• Investigators: Principal Investigator: Laura Hansen, MD, Northwell Health; Principal Investigator: Rafael Barrera, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: AP; Acute Pancreatitis; Feeding intolerance; Fat malabsorption; RELiZORB; EN support; Enteral nutrition (EN); Immobilized lipase cartridge; Digestive enzyme cartridge; Enteral nutrition intolerance
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 25-0106-LIJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Considering the small sample size, there is a concern for breach of confidentiality if IPD were shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes