[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629789":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":12,"locations":20,"responsibleParty":36,"collaborators":7,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":7,"studyType":53,"phases":7,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":65,"whyStopped":7,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9],{"name":10,"affiliation":5,"role":11},"Enrico Celestino Nista","PRINCIPAL_INVESTIGATOR",[13,17],{"name":10,"role":14,"phone":15,"phoneExt":7,"email":16},"CONTACT","+39 3298973569","enricocelestino.nista@policlinicogemelli.it",{"name":18,"role":14,"phone":19,"phoneExt":7,"email":7},"Sara Sofia De Lucia","+39 3391864962",[21],{"facility":22,"status":7,"city":23,"state":7,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Fondazione Policlinico Universitario A. Gemelli IRCCS","Rome","00168","Italy","IT",{"type":28,"coordinates":29},"Point",[30,31],12.51133,41.89193,{"lat":31,"lon":30},[34,35],{"name":10,"role":14,"phone":15,"phoneExt":7,"email":16},{"name":18,"role":14,"phone":7,"phoneExt":7,"email":7},{"type":11,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Nista Enrico Celestino","Principal Investigator","100629789","breath-test-based-assessment-of-sibo-in-chronic-pancreatitis-and-partial-pancreatectomy-100629789",false,"NCT07479238","Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy","Prevalence of SIBO in Patients With Chronic Pancreatitis and After Partial Pancreatectomy: Assessment by Glucose, Lactulose and Mixed Triglyceride Breath Tests.","DCP-PCT-EPI","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability and willingness to participate in the study and to comply with study procedures\n* Diagnosis of chronic pancreatitis with pancreatic exocrine insufficiency (defined as fecal elastase \\\u003C 200 µg\u002Fg of stool)\n* Ongoing pancreatic enzyme replacement therapy (PERT) with persistent gastrointestinal symptoms (including abdominal pain, dyspepsia, bloating, excessive flatulence, diarrhea, or steatorrhea) or unintentional weight loss ≥ 10% within the previous 6 months despite adequate PERT dosing (≥ 40,000 IU per main meal and half dose for snacks)\n* Patients with ampullary or pancreatic tumors who underwent partial pancreatectomy and subsequently developed pancreatic exocrine insufficiency with persistent gastrointestinal symptoms\n* Indication to undergo glucose, lactulose, and mixed triglyceride breath tests as part of routine clinical practice\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years or \\> 75 years\n* Pancreatic adenocarcinoma or bile duct tumors under active or previous adjuvant therapy\n* Moderate to severe liver disease\n* Severe chronic kidney disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* History of major gastrointestinal surgery, including total pancreatectomy\n* Presence of other active organic gastrointestinal diseases\n* Diabetic gastroparesis\n* Known celiac disease\n* Obstructive jaundice\n* Liver cirrhosis Child-Pugh class C\n* Recent or ongoing infections\n* Severe chronic obstructive pulmonary disease (COPD)\n* Symptomatic thyroid disorders\n* Use of antibiotics, laxatives, probiotics, or prokinetic agents within 4 weeks prior to breath testing\n* Inability or refusal to undergo study procedures\n* Inability or refusal to provide informed consent","ALL","18 Years","75 Years",{"count":51,"type":52},100,"ESTIMATED","OBSERVATIONAL","Pancreatic exocrine insufficiency (PEI) results from reduced pancreatic enzyme secretion, leading to malabsorption, malnutrition, and impaired quality of life. Although pancreatic enzyme replacement therapy (PERT) is the standard treatment, some patients remain symptomatic despite apparently adequate therapy. Possible causes include suboptimal dosing or concomitant conditions such as small intestinal bacterial overgrowth (SIBO). This study aims to determine the prevalence of SIBO in symptomatic PEI patients despite adequate PERT and to identify treatable causes of persistent symptoms using non-invasive diagnostic tests, with the goal of improving nutritional status and quality of life.",[56,57,58,59],"SIBO","Pancreatic Insufficiency","Chronic Pancreatitis","Pancreatic Surgey",[61,62,63,64],"Pancreatic exocrine insufficiency","Chronic pancreatitis","enzyme replacement therapy","Small intestinal bacterial overgrowth","NOT_YET_RECRUITING","2026-04-09",{"date":68,"type":69},"2026-04-13","ACTUAL",{"date":71,"type":52},"2026-04-30",{"date":73,"type":52},"2028-04-26",{"name":5,"class":6},1]