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

NCT07583342 | Enrolling By Invitation Phase 4 FDA Device

• 1 other identifier: 25-0106-LIJ
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Enhancing Enteral Nutrition Tolerance; Acute Pancreatitis (AP)

Keywords

RELiZORB; Acute Pancreatitis; AP; EN support; Enteral nutrition (EN); Immobilized lipase cartridge; Digestive enzyme cartridge; Feeding intolerance; Enteral nutrition intolerance; Fat malabsorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percent of goal nutrition delivered at 24 hours

  From enrollment to 24 hours after starting RELiZORB

• Responders at 72 hours

  From enrollment to end of treatment at 72 hours

• Responders at 24 hours

  From enrollment to 24 hours after starting treatment

• Vomiting

  From enrollment to completion of treatment at 72 hours

• Stool volume

  From enrollment to completion of treatment at 72 hours

Study Arms (1)

Relizorb treatment

EXPERIMENTAL

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

Interventions

RELiZORB digestive enzyme (immobilized lipase) cartridge DEVICE

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.

Relizorb treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Alcresta Therapeutics, Inc.: collaborator

Study Sites (5)

South Shore University Hospital

Bay Shore, New York, 11706, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Lenox Hill Hospital

Manhattan, New York, 10075, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Laura Hansen, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Rafael Barrera, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgical ICU, Surgery, Acute Care in Lenox Hill Hospital

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: May 13, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)