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Enrolling by Invitation

NCT Number: NCT07583342

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.

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Key information

Conditions

Acute Pancreatitis (AP) Digestive System Diseases Enhancing Enteral Nutrition Tolerance Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

South Shore University Hospital, Bay Shore, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percent of goal nutrition delivered at 72 hours

    Time frame: From enrollment to the end of treatment 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.

Secondary outcomes

  1. Percent of goal nutrition delivered at 24 hours

    Time frame: From enrollment to 24 hours after starting RELiZORB

    Change from baseline in goal percentage of enteral nutrition (kcal/kg/day) received 1 day (24 hours) following initiation of RELiZORB.

  2. Responders at 72 hours

    Time frame: From enrollment to end of treatment 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.

  3. Responders at 24 hours

    Time frame: From enrollment to 24 hours after starting treatment

    Percent of patients considered responders defined as receiving ≥80% of their daily enteral nutritional goal 1 day (24 hours) following initiation of RELiZORB use.

  4. Vomiting

    Time frame: From enrollment to completion of treatment at 72 hours

    Change in the number of vomiting episodes per 24 hour period from baseline to 24 and 72 hours following initiation of RELiZORB use

  5. Stool volume

    Time frame: From enrollment to completion of treatment at 72 hours

    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)

  6. Bowel movements

    Time frame: From enrollment to completion of treatment at 72 hours

    Change in number of bowel movement episodes in 24 hours from baseline to 24 hours and 72 hours after RELiZORB (if no rectal tube)

  7. Feeding Interruptions

    Time frame: From enrollment to completion of treatment at 72 hours

    Number of unplanned interruptions in tube feeding from baseline to 24 hours and 72 hours following initiation of RELiZORB use

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Alcresta Therapeutics, Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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