[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535806":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":52,"studyPopulation":53,"armGroups":48,"interventions":54,"overallOfficials":58,"centralContacts":62,"locations":71,"responsibleParty":90,"collaborators":48,"id":93,"slug":48,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":48,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":48,"studyType":105,"phases":48,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":74,"whyStopped":48,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"The Second Hospital of Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"The mean daily insulin dosage of participants","The mean daily insulin dosage of participants in past week","One-week, Two-week, Four-week post-WMT",[14,17,20,23,26,29,32,35,38,41,45],{"measure":15,"description":16,"timeFrame":12},"The Blood glucose of Time in Range (TIR, percent) of type 1 diabetes mellitus.","The proportion of time spent within the target blood sugar range (typically 3.9 to 10.0mmol\u002FL) over a 24-hour period",{"measure":18,"description":19,"timeFrame":12},"The SD of blood glucose (SDBG, mmol\u002FL) of type 1 diabetes mellitus.","The standard deviation of measured values during immediate blood glucose monitoring",{"measure":21,"description":22,"timeFrame":12},"The largest amplitude of glycemic excursions (LAGE, mmol\u002FL) of type 1 diabetes mellitus.","The range of blood glucose values observed during immediate blood glucose monitoring",{"measure":24,"description":25,"timeFrame":12},"The mean amplitude of glycemic excursion (MAGE, mmol\u002FL) of type 1 diabetes mellitus.","After filtering out blood glucose fluctuations below a certain threshold (usually 1 SD), the average fluctuation amplitude is calculated based on the direction of the first significant fluctuation",{"measure":27,"description":28,"timeFrame":12},"The mean of daily differences (MODD, mmol\u002FL) of type 1 diabetes mellitus.","The average absolute difference between corresponding measured values over a continuous 48-hour period",{"measure":30,"description":31,"timeFrame":12},"The postprandial glucose excursions (PPGE, mmol\u002FL) of type 1 diabetes mellitus.","The average absolute difference between post-meal blood glucose taken 2 hours after three meals and the corresponding pre-meal blood glucose.",{"measure":33,"description":34,"timeFrame":12},"The mean blood glucose (MBG, mmol\u002FL) of type 1 diabetes mellitus.","Average values obtained from immediate blood glucose monitoring",{"measure":36,"description":37,"timeFrame":12},"The coefficient of variation (CV, percent) of type 1 diabetes mellitus.","CV=(SDBG÷MBG)×100%",{"measure":39,"description":40,"timeFrame":12},"The frequency of hypoglycemia or duration of hypoglycemic state in the last 1 week","Hypoglycemia is defined as blood glucose \\\u003C 3.9 mmol\u002FL",{"measure":42,"description":43,"timeFrame":44},"The islet β-cell function after WMT compared with baseline","2-hour postprandial C-peptide release was used to reflect islet β-cell function","Three-day, One-week, Two-week, Four-week post-WMT",{"measure":46,"description":47,"timeFrame":12},"The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0","The severity of AE was graded as mild (grade 1), moderate (grade 2), severe\u002Fdisabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.)",null,{"allocation":48,"interventionModel":48,"interventionModelDescription":48,"primaryPurpose":48,"observationalModel":50,"timePerspective":51,"maskingInfo":48},"COHORT","PROSPECTIVE","At least 20 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, blood glucose fluctuation and variability, daily insulin dosage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.","National patients with T1DM receiving WMT will be enrolled.",[55],{"type":6,"name":56,"description":57,"armGroupLabels":48,"otherNames":48},"WMT","Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive three doses of WMT for T1DM.",[59],{"name":60,"affiliation":5,"role":61},"Faming Zhang, PhD","PRINCIPAL_INVESTIGATOR",[63,67],{"name":60,"role":64,"phone":65,"phoneExt":48,"email":66},"CONTACT","086-025-58509883","fzhang@njmu.edu.cn",{"name":68,"role":64,"phone":69,"phoneExt":48,"email":70},"Bota Cui","086-025-58509884","cuibota@njmu.edu.cn",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210011","China","CN",{"type":81,"coordinates":82},"Point",[83,84],118.77778,32.06167,{"lat":84,"lon":83},[87],{"name":88,"role":64,"phone":89,"phoneExt":48,"email":66},"Faming Zhang, MD, PhD","086-25-58509883",{"type":61,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Faming Zhang","Professor, Gastroenterology","100535806",false,"NCT06256614","Washed Microbiota Transplantation for Type 1 Diabetes Mellitus","Washed Microbiota Transplantation for Type 1 Diabetes Mellitus: a Real World Research","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to enter the study:\n\n1. At the time of informed consent, male or non-pregnant or non-lactating female.\n2. The diagnostic criteria for T1DM are confirmed by previous medical record.\n3. The subject or his\u002Fher legal representative gives informed consent, fully nderstands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria must be excluded from the study:\n\n1. Diagnosed as any type of diabetes other than type 1 diabetes mellitus;\n2. Subjects with severe life-threatening complications diabetes (such as ketoacidosis, or acute coronary syndrome, etc.);\n3. At the time of screening, the subject or his\u002Fher legal representative refuses to take effective contraception within 3 months after the last treatment.\n4. According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.","ALL","3 Years","100 Years",{"count":103,"type":104},50,"ESTIMATED","OBSERVATIONAL","This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation (WMT) for patients with Type 1 Diabetes Mellitus (T1DM).",[108],"Type 1 Diabetes",[110,111,112,113,114,115],"washed microbiota transplantation","type 1 diabetes mellitus","glycemic variability","daily insulin dosage","hypoglycemia","insulin sensitivity","2025-09-03",{"date":118,"type":119},"2025-09-10","ACTUAL",{"date":121,"type":119},"2024-03-01",{"date":123,"type":104},"2029-07",{"name":5,"class":6},1]