Nctid:
NCT06612411
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000043183", "term"=>"Irritable Bowel Syndrome"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000013577", "term"=>"Syndrome"}, {"id"=>"D000003967", "term"=>"Diarrhea"}], "ancestors"=>[{"id"=>"D000004194", "term"=>"Disease"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000003109", "term"=>"Colonic Diseases, Functional"}, {"id"=>"D000003108", "term"=>"Colonic Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000012817", "term"=>"Signs and Symptoms, Digestive"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "asFound"=>"Metabolism Disorders", "relevance"=>"HIGH"}, {"id"=>"M25118", "name"=>"Irritable Bowel Syndrome", "asFound"=>"Irritable Bowel Syndrome", "relevance"=>"HIGH"}, {"id"=>"M7159", "name"=>"Diarrhea", "asFound"=>"Diarrhea", "relevance"=>"HIGH"}, {"id"=>"M16010", "name"=>"Starvation", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M6337", "name"=>"Colonic Diseases, Functional", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M15622", "name"=>"Signs and Symptoms, Digestive", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["EARLY_PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>180}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-06-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-08-12", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The score of IBS-SSS before and after intervention", "timeFrame"=>"6 months"}], "secondaryOutcomes"=>[{"measure"=>"The concentration of purine in the stool before and after intervention", "timeFrame"=>"6 months"}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Irritable Bowel Syndrome with Diarrhea", "Purine Metabolism Disorder"]}, "descriptionModule"=>{"briefSummary"=>"This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Participants with IBS are recruited and randomized to receive a 4-week administration of B. subtilis-based probiotics. Clinical symptoms and stool samples are collected before and after the trial."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"16 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\nPatients are diagnosed with IBS. IBS was diagnosed based on the Rome IV criteria. Subjects aged from 16-80 years old without any gut medical conditions like inflammatory bowel diseases, infectious diarrhea, colon tumors were included.\n\nExclusion Criteria:\n\nSubjects who are taking any probiotics, PPIs, antibiotics or any drugs affecting uric acid levels for at least one month before the study.\n\nSubjects who decline to participate into the study."}, "identificationModule"=>{"nctId"=>"NCT06612411", "briefTitle"=>"B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis", "organization"=>{"class"=>"OTHER", "fullName"=>"Jinling Hospital, China"}, "officialTitle"=>"Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome", "orgStudyIdInfo"=>{"id"=>"No.2023DZKY-023-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"B. subtilis intervention", "interventionNames"=>["Drug: B. subtilis"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo capsules", "interventionNames"=>["Drug: Dead B. subtilis"]}], "interventions"=>[{"name"=>"B. subtilis", "type"=>"DRUG", "otherNames"=>["Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd"], "description"=>"2 capsules, 3 times a day, orally taken for one month", "armGroupLabels"=>["B. subtilis intervention"]}, {"name"=>"Dead B. subtilis", "type"=>"DRUG", "otherNames"=>["Medilac-s, S20030087, Beijing Hanmi Pharm.co.,Ltd"], "description"=>"2 capsules, 3 times a day, orally taken for one month", "armGroupLabels"=>["Placebo capsules"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Nanjing", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Fangyu Wang", "role"=>"CONTACT", "email"=>"wangfy65@nju.edu.cn", "phone"=>"02586800051"}, {"name"=>"Hui Tao", "role"=>"CONTACT", "email"=>"xhnk51@126.com", "phone"=>"02580860114"}], "facility"=>"Jinling Hospital", "geoPoint"=>{"lat"=>32.06167, "lon"=>118.77778}}, {"city"=>"Nanjing", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Fangyu Wang", "role"=>"CONTACT", "email"=>"wangfy65@nju.edu.cn", "phone"=>"025-80860051"}, {"name"=>"Hui Tao", "role"=>"CONTACT", "email"=>"xhnk51@126.com", "phone"=>"025-80860114"}], "facility"=>"Jinling Hospital", "geoPoint"=>{"lat"=>32.06167, "lon"=>118.77778}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"YES"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Jinling Hospital, China", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Fangyu Wang", "investigatorAffiliation"=>"Jinling Hospital, China"}}}}
