Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis
7. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Påmelding etter invitasjon
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
15
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New York
-
Bay Shore, New York, Forente stater, 11706
- South Shore University Hospital
-
Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
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Manhattan, New York, Forente stater, 10075
- Lenox Hill Hospital
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New Hyde Park, New York, Forente stater, 11040
- Long Island Jewish Medical Center
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Staten Island, New York, Forente stater, 10305
- Staten Island University Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Laura Hansen, MD, Northwell Health
- Hovedetterforsker: Rafael Barrera, MD, Northwell Health
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. desember 2025
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
9. mars 2026
Først innsendt som oppfylte QC-kriteriene
7. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 25-0106-LIJ
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Considering the small sample size, there is a concern for breach of confidentiality if IPD were shared.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
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