[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07583342":3,"trial-entities:NCT07583342":144,"trial-summary:NCT07583342":147},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":46,"secondary_outcomes":51,"sex":77,"minimum_age":78,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":94,"locations":97,"central_contacts":135,"overall_officials":136,"references":142,"see_also_links":143},"NCT07583342","25-0106-LIJ","Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis","Open-label, Multicenter, Phase IV, Study Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis","ENROLLING_BY_INVITATION","2026-12","2026-05","2026-05-13","2025-12-08","Northwell Health","OTHER",false,"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:\n\nDoes Relizorb allow more nutrition to be delivered to participants than they received without it?\n\nParticipants will be observed with standard, universal monitoring after adding Relizorb to their nutrition regimen.",null,[19,20],"Acute Pancreatitis (AP)","Enhancing Enteral Nutrition Tolerance",[22,23,24,25,26,27,28,29,30,31],"RELiZORB","Acute Pancreatitis","AP","EN support","Enteral nutrition (EN)","Immobilized lipase cartridge","Digestive enzyme cartridge","Feeding intolerance","Enteral nutrition intolerance","Fat malabsorption","INTERVENTIONAL","TREATMENT",[35],"PHASE4",{"count":37,"type":38},15,"ESTIMATED",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44},"DEVICE","RELiZORB digestive enzyme (immobilized lipase) cartridge","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.",[45],"Relizorb treatment",[47],{"measure":48,"description":49,"timeFrame":50},"Percent of goal nutrition delivered at 72 hours","Change from baseline in percentage of goal enteral nutrition (kcal\u002Fkg\u002Fday) 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",[52,56,60,64,68,71,74],{"measure":53,"description":54,"timeFrame":55},"Percent of goal nutrition delivered at 24 hours","Change from baseline in goal percentage of enteral nutrition (kcal\u002Fkg\u002Fday) received 1 day (24 hours) following initiation of RELiZORB.","From enrollment to 24 hours after starting RELiZORB",{"measure":57,"description":58,"timeFrame":59},"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.","From enrollment to end of treatment at 72 hours",{"measure":61,"description":62,"timeFrame":63},"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.","From enrollment to 24 hours after starting treatment",{"measure":65,"description":66,"timeFrame":67},"Vomiting","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",{"measure":69,"description":70,"timeFrame":67},"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)",{"measure":72,"description":73,"timeFrame":67},"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)",{"measure":75,"description":76,"timeFrame":67},"Feeding Interruptions","Number of unplanned interruptions in tube feeding from baseline to 24 hours and 72 hours following initiation of RELiZORB use","ALL","18 Years",{"inclusion":80,"exclusion":85,"raw_text":93},[81,82,83,84],"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\u002Fkg\u002Fd)",[86,87,88,89,90,91,92],"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","Inclusion Criteria:\n\n* Male or female aged 18 + years of age\n* Admission to the Surgical Intensive Care Unit in the Northwell Health hospital system\n* Moderate to severe acute pancreatitis based on Atlanta criteria\n* Inability to tolerate ≥75% of goal EN (25 kcal\u002Fkg\u002Fd)\n\nExclusion Criteria:\n\n* Moribund patients expected to expire within 120 hours\n* Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition\n* Diagnosis or evidence of C. Difficile or other gastrointestinal infection that may manifest with diarrhea\n* Pre-existing constipation defined as laxative or stool softener use prior to admission to the hospital\n* Patients receiving cancer-related treatment in the last 3 months\n* History of cystic fibrosis\n* Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition",[95,96],"ADULT","OLDER_ADULT",[98,107,114,121,128],{"facility":99,"city":100,"state":101,"zip":102,"country":103,"geoPoint":104},"South Shore University Hospital","Bay Shore","New York","11706","United States",{"lat":105,"lon":106},40.7251,-73.24539,{"facility":108,"city":109,"state":101,"zip":110,"country":103,"geoPoint":111},"North Shore University Hospital","Manhasset","11030",{"lat":112,"lon":113},40.79788,-73.69957,{"facility":115,"city":116,"state":101,"zip":117,"country":103,"geoPoint":118},"Lenox Hill Hospital","Manhattan","10075",{"lat":119,"lon":120},40.78343,-73.96625,{"facility":122,"city":123,"state":101,"zip":124,"country":103,"geoPoint":125},"Long Island Jewish Medical Center","New Hyde Park","11040",{"lat":126,"lon":127},40.7351,-73.68791,{"facility":129,"city":130,"state":101,"zip":131,"country":103,"geoPoint":132},"Staten Island University Hospital","Staten Island","10305",{"lat":133,"lon":134},40.56233,-74.13986,[],[137,140],{"name":138,"affiliation":13,"role":139},"Laura Hansen, MD","PRINCIPAL_INVESTIGATOR",{"name":141,"affiliation":13,"role":139},"Rafael Barrera, MD",[],[],{"nct_id":4,"conditions":145,"biomarkers":146},[23],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]