[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053727":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":25,"responsibleParty":41,"collaborators":44,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":25,"enrollmentInfo":57,"targetDuration":25,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":25},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-porcine microbial (fungal) based pancreatic enzyme preparation","EXPERIMENTAL","The non-porcine microbial enzyme preparation will contain amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC)",[13],"Dietary Supplement: Dietary Supplement: Pancreatic enzyme preparation from microbial (fungal) source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC).",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care porcine pancreatic enzyme","ACTIVE_COMPARATOR","The standard of care porcine-based enzyme preparation will contain amylase (8000 U), lipase (25000 U), and protease (1000 U)",[19],"Other: Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U)",[21,26],{"type":22,"name":23,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Dietary Supplement: Pancreatic enzyme preparation from microbial (fungal) source that contains amylase (6650 DU), lipase (13000 FIP), and protease (7120 HUT, 15 SAPU, 3000 PC).",[9],null,{"type":6,"name":27,"description":27,"armGroupLabels":28,"otherNames":25},"Standard of care porcine pancreatic enzyme preparation: amylase (8000 U), lipase (25000 U), and protease (1000 U)",[15],[30],{"name":31,"affiliation":32,"role":33},"Rupjyoti Talukdar, MD","Asian Institute of Gastroenterology","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+917032804231","rup_talukdar@yahoo.com",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":25},"Abdul Rasheed, PharmD",{"type":33,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Rupjyoti Talukdar","Director, Pancreatology",[45],{"name":46,"class":6},"Aalborg University","100053727","phase-3-comparative-study-to-evaluate-microbial-versus-porcine-pancreatic-enzyme-therapy-in-chronic-pancreatitis-100053727",false,"NCT07697352","Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis","A Randomised, Double-Blind, Non-Inferiority Trial Comparing Microbial and Porcine Pancreatic Enzyme Replacement Therapy in Chronic Pancreatitis","NP-PERT","Inclusion Criteria:\n\n* CP fulfilling the M-ANNHEIM criteria 11 with documented PEI (defined as fecal elastase \\\u003C100 µg\u002Fg stool on the background of morphological changes of CP).\n* Willingness to undergo a 2-week wash-out period without pancreatic enzyme therapy before enrolment.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Major psychiatric illness impairing study participation.\n* Systemic illness affecting digestion or study outcomes.\n* Any condition deemed unsuitable for study participation by the investigator.\n* Concurrent acute exacerbation of the CP at the time of screening.","ALL","18 Years",{"count":58,"type":59},134,"ESTIMATED","INTERVENTIONAL",[62],"PHASE3","Background: Chronic pancreatitis (CP) is a progressive inflammatory disorder causing irreversible pancreatic damage, eventually resulting in pancreatic exocrine insufficiency (PEI). This may lead to malabsorption, malnutrition, weight loss, and impaired quality of life. Pancreatic enzyme replacement therapy (PERT) is the standard treatment for PEI and is predominantly derived from porcine sources. However, religious, ethical, dietary, and supply-related concerns highlight the need for effective non-porcine alternatives. Microbial (fungal)-based pancreatic enzymes have shown promising safety and efficacy in preliminary studies, but evidence in CP remains limited.\n\nObjective: To compare the efficacy and safety of non-porcine microbial (fungal)-based pancreatin with standard porcine-based pancreatin in patients with PEI secondary to CP.\n\nMethods: This investigator-initiated, randomized, double-blind, single-center, non-inferiority trial will enroll 134 adults with CP-associated PEI (defined as having a fecal elastase \\\u003C100 µg\u002Fg). After a two-week washout period, participants will be randomized 1:1 to receive either microbial-based or porcine-based pancreatin for 12 weeks. The primary outcome is the change from baseline in the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) score at 12 weeks. Secondary outcomes include nutritional status, anthropometric measures, gastrointestinal symptoms, pain scores, stool consistency, glycaemic parameters, laboratory markers, and quality of life.\n\nDiscussion: This study aims to evaluate whether microbial-based pancreatin is non-inferior to porcine-based therapy and may provide a culturally acceptable and sustainable alternative for managing CP-related PEI.",[65,66],"Pancreatitis, Chronic","Exocrine Pancreatic Insufficiency (EPI)",[68,69,70,71,72],"chronic pancreatitis","exocrine pancreatic insufficiency","Pancreatic enzyme replacement therapy","porcine pancreatic enzyme","microbial (fungal) pancreatic enzyme","NOT_YET_RECRUITING","2026-07-05",{"date":76,"type":77},"2026-07-13","ACTUAL",{"date":79,"type":59},"2026-08",{"date":81,"type":59},"2027-09",{"name":5,"class":6}]