Acute Pancreatitis (AP)Phase 4NCT07583342
Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis
A Phase 4 study testing RELiZORB digestive enzyme (immobilized lipase) cartridge in people with Acute Pancreatitis (AP) and Enhancing Enteral Nutrition Tolerance, run by Northwell Health at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis (AP), Enhancing Enteral Nutrition Tolerance
- What is being tested?
- RELiZORB digestive enzyme (immobilized lipase) cartridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Dec 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
South Shore University Hospital
Bay Shore, New York, 11706
North Shore University Hospital
Manhasset, New York, 11030
Lenox Hill Hospital
Manhattan, New York, 10075
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Staten Island University Hospital
Staten Island, New York, 10305
About this study
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
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.
- Being tested
- RELiZORB digestive enzyme (immobilized lipase) cartridge
- Keywords
- RELiZORB, Acute Pancreatitis, AP, EN support, Enteral nutrition (EN), Immobilized lipase cartridge, Digestive enzyme cartridge, Feeding intolerance, Enteral nutrition intolerance, Fat malabsorption
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELiZORB digestive enzyme (immobilized lipase) cartridgeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RELiZORB digestive enzyme (immobilized lipase) cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 72 hours
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: From enrollment to completion of treatment at 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start8 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis (AP)Studies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Alcresta Therapeutics, Inc.
- Responsible party
- Principal investigator, Laura Hansen, Northwell Health
- Investigators
- Laura Hansen, MD, Principal investigator, Northwell HealthRafael Barrera, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583342
- Sponsor's protocol ID
- 25-0106-LIJ
- Status last verified
- May 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Considering the small sample size, there is a concern for breach of confidentiality if IPD were shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07583342
- Acronym / sponsor ID
- 25-0106-LIJ
- Keywords
- RELiZORB, Acute Pancreatitis, AP, EN support, Enteral nutrition (EN), Immobilized lipase cartridge, Digestive enzyme cartridge, Feeding intolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Alcresta Therapeutics, Inc.
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relizorb treatment | Experimental | Device: RELiZORB digestive enzyme (immobilized lipase) cartridgePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELiZORB digestive enzyme (immobilized lipase) cartridgeAn 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. | Device | Relizorb treatment |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Considering the small sample size, there is a concern for breach of confidentiality if IPD were shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Hansen, MD principal investigator
Northwell Health
Rafael Barrera, MD principal investigator
Northwell Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RELiZORB digestive enzyme (immobilized lipase) cartridge in people with Acute Pancreatitis (AP) and Enhancing Enteral Nutrition Tolerance, run by Northwell Health at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of goal nutrition delivered at 72 hours (time frame: From enrollment to the end of treatment at 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.