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Clinical Trials/NCT07583342
NCT07583342Enrolling By InvitationPhase 4

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

Northwell Health5 sites in 1 country15 target enrollmentStarted: December 8, 2025Last updated:

Trial Snapshot

Phase
Phase 4
Status
Enrolling By Invitation
Enrollment
15
Locations
5

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Hansen

Director of Surgical ICU, Surgery, Acute Care in Lenox Hill Hospital

Northwell Health

Study Sites (5)

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