Menu
Enrolling by invitation NCT07583342

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

Phase IV Interventional Acute Pancreatitis (AP) Enhancing Enteral Nutrition Tolerance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RELiZORB digestive enzyme (immobilized lipase) cartridge.
Who it may be relevant to
Registry conditions: Acute Pancreatitis (AP), Enhancing Enteral Nutrition Tolerance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Percent of goal nutrition delivered at 72 hours [Time frame: From enrollment to the end of treatment at 72 hours]
Secondary outcome measures (7)
  • Percent of goal nutrition delivered at 24 hours [Time frame: From enrollment to 24 hours after starting RELiZORB]
  • Responders at 72 hours [Time frame: From enrollment to end of treatment at 72 hours]
  • Responders at 24 hours [Time frame: From enrollment to 24 hours after starting treatment]
  • Vomiting [Time frame: From enrollment to completion of treatment at 72 hours]
  • Stool volume [Time frame: From enrollment to completion of treatment at 72 hours]
  • Bowel movements [Time frame: From enrollment to completion of treatment at 72 hours]
  • Feeding Interruptions [Time frame: From enrollment to completion of treatment at 72 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • South Shore University Hospital — Bay Shore
  • North Shore University Hospital — Manhasset
  • Lenox Hill Hospital — Manhattan
  • Long Island Jewish Medical Center — New Hyde Park
  • Staten Island University Hospital — Staten Island

Identifiers

NCT: NCT07583342 · 25-0106-LIJ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗