[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574224":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":16,"locations":7,"responsibleParty":22,"collaborators":7,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":31,"acronym":7,"eligibilityCriteria":32,"healthyVolunteers":28,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":7,"studyType":39,"phases":7,"briefSummary":40,"conditions":41,"keywords":44,"overallStatus":48,"whyStopped":7,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":7},{"fullName":5,"class":6},"Hospital de Clinicas José de San Martín","OTHER",null,[9,13],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","fecal elastase","To investigate exocrine pancreatic insufficiency (EPI), all patients will be asked to provide a stool sample for fecal elastase (Fel-1) analysis. Participants will be instructed to collect their stool sample in a sterile, disposable plastic container and submit it to the Gastroenterology Chemistry Laboratory (Litwin Laboratory) for processing and analysis. Based on previously published reports, samples will be refrigerated at 4-8 °C for no more than 48 hours. The concentration of Fel-1 in all samples will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (ScheBo-Pancreatic Elastase 1™, Giessen, Germany), with fecal elastase extracted and analyzed according to the manufacturer's instructions.",{"type":10,"name":14,"description":15,"armGroupLabels":7,"otherNames":7},"Serum cytokines","Cytokines will be quantified using the Bio-Plex Pro™ Human Cytokine 27-plex commercial kit (Bio-Rad Laboratories, USA) following the kit instructions.",[17],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},"MARIA M PISKORZ, MD","CONTACT","+5491133192885","neurogastrohc@gmail.com",{"type":23,"investigatorFullName":24,"investigatorTitle":25,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","Maria Marta Piskorz","Principal Investigator","100574224","exocrine-pancreatic-insufficiency-and-functional-dyspepsia-100574224",false,"NCT06756503","Exocrine Pancreatic Insufficiency and Functional Dyspepsia","Prevalence and Clinical Characteristics of Exocrine Pancreatic Insufficiency in Patients With Functional Dyspepsia","Inclusion Criteria:\n\n* Patients over 18 years of age diagnosed with functional dyspepsia based on Rome IV criteria, who have been excluded for organic, metabolic, and medication-related causes (NSAIDs), and who test negative for H. pylori.\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Organic diseases of the digestive tract (celiac disease, inflammatory bowel diseases, neoplasms, positive for H. pylori)\n* Uncontrolled systemic diseases (diabetes mellitus, hypo- or hyperthyroidism, cancer, etc.)\n* Lack of informed consent\n* Severe psychiatric disorders, defined based on the DSM-5","ALL","18 Years","65 Years",{"count":37,"type":38},65,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the prevalence of exocrine pancreatic insufficiency in patients with functional dyspepsia .\n\n. The main questions it aims to answer are: What is the prevalence of exocrine pancreatic insufficiency (EPI) in patients with functional dyspepsia? Wich are the clinical characteristics associated with (EPI) in patients with functional dyspepsia? Patients diagnosed with functional dyspepsia will undergo an evaluation of clinical symptoms and fecal elastase determination. In those with fecal elastase levels below 100 µg\u002Fg, an endoscopic ultrasound and other assessments will be performed to define the cause of exocrine pancreatic insufficiency (EPI).",[42,43],"Exocrine Pancreatic Insufficiency","Dyspepsia",[45,46,47],"Exocrine pancreatic insufficiency","Functional dyspepsia","Fecal elastase","NOT_YET_RECRUITING","2025-08-05",{"date":51,"type":52},"2025-08-08","ACTUAL",{"date":54,"type":38},"2025-09-01",{"date":56,"type":38},"2026-08-01",{"name":24,"class":6}]