Nctid:
NCT06230432
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010195", "term"=>"Pancreatitis"}], "ancestors"=>[{"id"=>"D000010182", "term"=>"Pancreatic Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M13115", "name"=>"Pancreatitis", "asFound"=>"Pancreatitis", "relevance"=>"HIGH"}, {"id"=>"M13102", "name"=>"Pancreatic Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>176}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01-21", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-12-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-20", "studyFirstSubmitDate"=>"2023-12-29", "studyFirstSubmitQcDate"=>"2024-01-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Composition of gut microbiota", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"The gut microbiota plays an important role in protecting the intestinal barrier, regulating metabolism, and participating in immune responses in the human body, and is an important component of the gut ecosystem."}, {"measure"=>"Composition of gut metabolites", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"Metabolites can reveal the intrinsic correlation between metabolic products and physiological and pathological changes in the body, thereby achieving recognition of the overall state of the body."}, {"measure"=>"Composition of metabolites in plasma", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"Metabolites can reveal the intrinsic correlation between metabolic products and physiological and pathological changes in the body, thereby achieving recognition of the overall state of the body."}, {"measure"=>"composition of proteins in plasma", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"Proteins are an important material foundation for life activities and the main executors of life processes such as cell proliferation, differentiation, aging, and death."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Acute Pancreatitis"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to learn about the biomarkers and mechanisms of severe acute pancreatitis in 30 healthy controls, 30 patients of mild acute pancreatitis, 30 patients of moderately severe acute pancreatitis, and 86 patients of severe acute pancreatitis. The main question it aims to answer are: • The relationship between changes in gut microbiota and clinical prognosis (plasma inflammatory cytokines, incidence and duration of infection in various parts, mortality rate), and the screening and validation of biomarkers that can be used for early prediction of disease severity. • Analyze the relationship between changes in blood composition and clinical prognosis (plasma inflammatory cytokines, incidence and duration of infection in various parts, mortality rate), screen and verify biomarkers that can be used for early prediction of disease severity. Blood and fecal samples from the healthy control group and diagnosed patients will be collected."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"30 healthy controls, 30 patients of mild acute pancreatitis, 30 patients of moderately severe acute pancreatitis and 86 patients of severe acute pancreatitis, a total of 176 cases were included.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\nPatients group:\n\n① Age between 18 and 75 years old;\n\n② Within 72 hours of AP onset;\n\n③ AP patients who meet the 2012 Atlanta AP Classification and Diagnostic Criteria.\n\nHealthy control group:\n\n* Age between 18 and 75 years old; ② No history of acute pancreatitis; ③ Routine laboratory tests such as blood routine and fecal routine are normal.\n\nExclusion Criteria:\n\n* Used antibiotics, probiotics, and acid suppressants 4 weeks before enrollment;\n\n * Pregnant and lactating women;\n\n * Hypothyroidism, nephrotic syndrome, Cushing's syndrome, AIDS;\n\n * Chronic pancreatitis, pancreatic cancer; ⑤ Severe history of cardiovascular and cerebrovascular diseases and organ dysfunction, such as malignant tumors, heart failure, coronary heart disease, chronic obstructive pulmonary disease, liver and kidney failure; ⑥ Unsigned informed consent form."}, "identificationModule"=>{"nctId"=>"NCT06230432", "briefTitle"=>"Exploring the Mechanism of Severe Acute Pancreatitis Based on Metagenomics, Metabolomics and Proteomics", "organization"=>{"class"=>"OTHER", "fullName"=>"The First Affiliated Hospital of Nanchang University"}, "officialTitle"=>"Exploring the Mechanism of Severe Acute Pancreatitis Based on Metagenomics, Metabolomics and Proteomics", "orgStudyIdInfo"=>{"id"=>"FAH of NCU gastroenterology"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"healthy control"}, {"label"=>"mild acute pancreatitis"}, {"label"=>"moderately severe acute pancreatitis"}, {"label"=>"severe acute pancreatitis"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"330006", "city"=>"Nanchang", "state"=>"Jiangxi", "country"=>"China", "facility"=>"The First Affiliated Hospital of Nanchang University", "geoPoint"=>{"lat"=>28.68396, "lon"=>115.85306}}], "centralContacts"=>[{"name"=>"Yin Zhu, phD", "role"=>"CONTACT", "email"=>"zhuyin27@sina.com", "phone"=>"+8613970841464"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The First Affiliated Hospital of Nanchang University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Lingyu Luo", "investigatorAffiliation"=>"The First Affiliated Hospital of Nanchang University"}}}}
