Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis
7. maj 2026 opdateret af: Laura Hansen, Northwell Health
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.
Studieoversigt
Status
Tilmelding efter invitation
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
15
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
Bay Shore, New York, Forenede Stater, 11706
- South Shore University Hospital
-
Manhasset, New York, Forenede Stater, 11030
- North Shore University Hospital
-
Manhattan, New York, Forenede Stater, 10075
- Lenox Hill Hospital
-
New Hyde Park, New York, Forenede Stater, 11040
- Long Island Jewish Medical Center
-
Staten Island, New York, Forenede Stater, 10305
- Staten Island University Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Relizorb treatment
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent of goal nutrition delivered at 72 hours
Tidsramme: 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.
|
From enrollment to the end of treatment at 72 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent of goal nutrition delivered at 24 hours
Tidsramme: 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.
|
From enrollment to 24 hours after starting RELiZORB
|
|
Responders at 72 hours
Tidsramme: 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.
|
From enrollment to end of treatment at 72 hours
|
|
Responders at 24 hours
Tidsramme: 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.
|
From enrollment to 24 hours after starting treatment
|
|
Vomiting
Tidsramme: 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
|
From enrollment to completion of treatment at 72 hours
|
|
Stool volume
Tidsramme: 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)
|
From enrollment to completion of treatment at 72 hours
|
|
Bowel movements
Tidsramme: 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)
|
From enrollment to completion of treatment at 72 hours
|
|
Feeding Interruptions
Tidsramme: 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
|
From enrollment to completion of treatment at 72 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Laura Hansen, MD, Northwell Health
- Ledende efterforsker: Rafael Barrera, MD, Northwell Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. december 2025
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
9. marts 2026
Først indsendt, der opfyldte QC-kriterier
7. maj 2026
Først opslået (Faktiske)
13. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25-0106-LIJ
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Considering the small sample size, there is a concern for breach of confidentiality if IPD were shared.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .