[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553531":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":32,"studyPopulation":24,"armGroups":33,"interventions":52,"overallOfficials":71,"centralContacts":75,"locations":84,"responsibleParty":97,"collaborators":24,"id":100,"slug":24,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":24,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":24,"enrollmentInfo":108,"targetDuration":24,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":122,"whyStopped":24,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"The Second Hospital of Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Reticulocyte haemoglobin values in blood","To compare the level of reticulocyte haemoglobin in the blood before and after administration of iron lactate, iron sucrose and saline.","Baseline; Day 4",[14],{"measure":15,"description":16,"timeFrame":12},"Serum ferritin levels","To compare the level of ferritin in the serum before and after administration of iron lactate, iron sucrose and saline.",[18],{"measure":19,"description":20,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events","The number of adverse reactions that are associated with iron medicine reported by subjects from the start of treatment to the end of follow-up.",{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":24,"timePerspective":24,"maskingInfo":26},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":27,"maskingDescription":24,"whoMasked":28},"TRIPLE",[29,30,31],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","At least 60 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, reticulocyte hemoglobin, ferritin and clinical outcomes will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.",[34,40,46],{"label":35,"type":36,"description":37,"interventionNames":38},"Ferrous Lactate","EXPERIMENTAL","Ferrous lactate is administered via the colon as an injectable solution at a dose of 300 mg per day for 3 days, with saline added to 50ml.",[39],"Drug: Ferrous Lactate",{"label":41,"type":42,"description":43,"interventionNames":44},"Iron Sucrose","ACTIVE_COMPARATOR","Iron sucrose is administered via the colon as an injectable solution at a dose of 300mg per day for 3 days, with saline added to 50ml.",[45],"Drug: Iron sucrose",{"label":47,"type":48,"description":49,"interventionNames":50},"Saline","PLACEBO_COMPARATOR","0.9% sodium chloride is administered via the colon as an injectable solution at a dose of 50ml per day for 3 days.",[51],"Drug: 0.9% NaCl solution",[53,59,65],{"type":54,"name":35,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","The injection solution was 3 ferrous lactate (10ml:0.1g iron) mixed with 20ml saline.",[35],[58],"PURAMEX(R)",{"type":54,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"Iron sucrose","The injection was 3 shots of ferrous lactate (5ml:100mg iron) mixed with 35ml saline.",[41],[64],"Iron saccharate",{"type":54,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"0.9% NaCl solution","The same volume and color as Iron sucrose.",[47],[70],"saline (medicine)",[72],{"name":73,"affiliation":5,"role":74},"Faming Faming, PhD","PRINCIPAL_INVESTIGATOR",[76,80],{"name":73,"role":77,"phone":78,"phoneExt":24,"email":79},"CONTACT","02558509670","fzhang@njmu.edu.cn",{"name":81,"role":77,"phone":82,"phoneExt":24,"email":83},"Bota Cui","02558509883","cuibota@njmu.edu.cn",[85],{"facility":86,"status":24,"city":87,"state":88,"zip":24,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":24},"Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University","Nanjing","Jiangsu","China","CN",{"type":92,"coordinates":93},"Point",[94,95],118.77778,32.06167,{"lat":95,"lon":94},{"type":74,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Faming Zhang","Professor, Gastroenterology","100553531",false,"NCT06487299","Iron Administration Via Colonic TET Combined With WMT for ID","Iron Administration Via Colonic Transendoscopic Enteral Tubing Combined With Washed Microbiota Transplantation for Iron Deficiency:A Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n1. ferritin ≤30 μg\u002FL;\n2. feasible colonic TET placement (cephalic end in the ileocecal region);\n3. completion of 3 WMT sessions.\n\nExclusion Criteria:\n\n1. The patient has other co-morbidities that can lead to iron deficiency, such as acute gastrointestinal haemorrhage and menorrhagia.etc.\n2. People who are allergic to iron or taking oral medications that interfere with iron absorption.\n3. Patients with heart, brain, lung, liver, kidney and other serious diseases;\n4. Patients do not cooperate to complete the clinical trial process;","ALL","18 Years",{"count":109,"type":110},60,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","The colon can absorb iron.We propose an integrated approach utilizing colonic transendoscopic enteral tubing to deliver iron in different valence states, coupled with washed microbiota transplantation . This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for the treatment of iron deficiency.",[116],"Iron Deficiency Anemia in Childbirth",[118,119,120,121],"Iron","Transendoscopic enteral tubing","Washed Microbiota Transplantation","iron deficiency","NOT_YET_RECRUITING","2024-07-19",{"date":125,"type":126},"2024-07-22","ACTUAL",{"date":128,"type":110},"2024-07-25",{"date":130,"type":110},"2026-06-01",{"name":5,"class":6},1]