[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625127":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":57,"centralContacts":61,"locations":70,"responsibleParty":106,"collaborators":110,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":43,"enrollmentInfo":130,"targetDuration":43,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":94,"whyStopped":43,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,15,19,24,29,33],{"label":9,"type":10,"description":11,"interventionNames":12},"MBT1-MBT2","ACTIVE_COMPARATOR","Participants will undergo the MBT off PERT followed by the MBT on PERT. They will not be enrolled in the randomized trial.",[13,14],"Diagnostic Test: MBT1","Diagnostic Test: MBT 2",{"label":16,"type":10,"description":17,"interventionNames":18},"MBT2-MBT1","Participants will undergo MBT on PERT followed by MBT off PERT. Participants will not be enrolled in the randomized clinical trial.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"MBT1-MBT2 Pancreatic Enzyme","Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with PERT.",[23,13,14],"Drug: Pancreatic Enzyme Replacement Therapy",{"label":25,"type":10,"description":26,"interventionNames":27},"MBT1-MBT2 Placebo","Participants will undergo MBT off PERT followed by MBT on PERT, and subsequently be randomized to the clinical trial arm treated with placebo.",[28,13,14],"Drug: Placebo",{"label":30,"type":10,"description":31,"interventionNames":32},"MBT2-MBT1 PERT","Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with PERT.",[23,13,14],{"label":34,"type":10,"description":35,"interventionNames":36},"MBT2-MBT1 Placebo","Participants will undergo MBT on PERT followed by MBT off PERT, and subsequently be randomized to the clinical trial arm treated with placebo.",[28,13,14],[38,44,48,53],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","Pancreatic Enzyme Replacement Therapy","12 participants who are PERT responders in the MBT will be randomized to receive 8 weeks of PERT (144,000 lipase units daily)",[20,30],null,{"type":39,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"Placebo","12 participants who are PERT responders in the MBT will be assigned to receive 8 weeks of placebo therapy",[25,34],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":43},"DIAGNOSTIC_TEST","MBT1","MBT off PERT",[9,20,25,16,30,34],{"type":49,"name":54,"description":55,"armGroupLabels":56,"otherNames":43},"MBT 2","MBT on PERT",[9,20,25,16,30,34],[58],{"name":59,"affiliation":5,"role":60},"Anna E Phillips, MD MS","PRINCIPAL_INVESTIGATOR",[62,66],{"name":59,"role":63,"phone":64,"phoneExt":43,"email":65},"CONTACT","412-864-7096","Evansac3@upmc.edu",{"name":67,"role":63,"phone":68,"phoneExt":43,"email":69},"Apsara Mishra, BSC","412-383-2447","apm179@pitt.edu",[71,92],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Johns Hopkins Medicine","NOT_YET_RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-76.61219,39.29038,{"lat":83,"lon":82},[86,90],{"name":87,"role":63,"phone":88,"phoneExt":43,"email":89},"Yeganeh Pasebani, MD","410-955-5000","ypaseba1@jh.edu",{"name":91,"role":60,"phone":43,"phoneExt":43,"email":43},"Vikesh K Singh, MD MSc",{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":77,"countryCode":78,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"University of Pittsburgh Medical Center","RECRUITING","Pittsburgh","Pennsylvania","15213",{"type":80,"coordinates":99},[100,101],-79.99589,40.44062,{"lat":101,"lon":100},[104],{"name":59,"role":63,"phone":64,"phoneExt":43,"email":105},"evansac3@upmc.edu",{"type":107,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Anna Evans Phillips","Assistant Professor",[111,113,116,118],{"name":112,"class":6},"Johns Hopkins University",{"name":114,"class":115},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"name":117,"class":6},"Children's Hospital of Philadelphia",{"name":119,"class":120},"Digestive Care, Inc.","INDUSTRY","100625127","phase-4-malabsorption-blood-test-mbt-to-determine-exocrine-pancreatic-function-and-related-quality-of-life-in-chronic-pancreatitis-100625127",false,"NCT07418593","Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis","MBT","Inclusion Criteria\n\n* ≥ 18 years of age\n* RAP (≥ 2 documented lifetime attacks with ≥ 2 of 3 acute pancreatitis criteria) OR Chronic pancreatitis (Cambridge I or II with documented history of AP OR Cambridge III or IV criteria)\n* Fecal elastase ≥ 50 within the preceding 12 months\n\nExclusion Criteria\n\n* Allergy\u002FIntolerance to PERT\u002FMBT\n* Taking medications that alter fat absorption or that supplement the fatty acids being studied (e.g. orlistat, ursodeoxycholic acid, Fatty-15 fatty acid supplement etc.)\n* Taking GLP-1 Receptor Agonist therapy\n* Fecal elastase \\\u003C50 within preceding 12 months OR pre-existing diagnosis of severe Exocrine Pancreatic Insufficiency, or ongoing steatorrhea\n* Receiving Pancreatic Enzyme Replacement Therapy for \\> 5 days within the preceding 30 days\n* Acute Pancreatitis attack (documented and meeting at least 2 of 3 criteria) within the preceding 90 days\n* History of pancreatic resection or underlying malabsorptive disease\n* Pregnant or Breast Feeding\n* Other significant medical condition as judged by Principal Investigator","ALL","18 Years",{"count":131,"type":132},80,"ESTIMATED","INTERVENTIONAL",[135],"PHASE4","This project uses the Malabsorption Blood Test (MBT) to identify patients with recurrent acute or chronic pancreatitis who have mild to moderate exocrine pancreatic insufficiency. A subgroup of patients who have response to pancreatic enzyme replacement therapy will enter a randomized, placebo-controlled pilot clinical trial for 8 weeks to identify improvements in quality of life (QOL).",[138,139,140],"Chronic Pancreatitis","Recurrent Acute Pancreatitis","Exocrine Pancreatic Insufficiency",[142,143,144,140],"Malabsorption Blood Test(MBT)","Chronic pancreatitis","Recurrent Acute pancreatitis","2026-04-21",{"date":147,"type":148},"2026-04-27","ACTUAL",{"date":150,"type":148},"2026-04-20",{"date":152,"type":132},"2028-09",{"name":108,"class":6},2]