[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650978":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":20,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":20,"overallStatus":65,"whyStopped":20,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FMT Treatment Group","EXPERIMENTAL","Oral administration of human-derived gut microbiota capsules, each containing no fewer than 2×10¹¹ organisms, given at a dose of 20 capsules per day for 3 consecutive days (total 60 capsules per course).",[13],"Biological: Fecal microbiota transplantation (FMT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Fecal microbiota transplantation (FMT)","The FMT capsules are prepared from healthy donor feces screened according to international consensus guidelines. Oral administration of human-derived gut microbiota capsules, each containing no fewer than 2×10¹¹ organisms, given at a dose of 20 capsules per day for 3 consecutive days (total 60 capsules per course).No dose adjustments will be made during the study. The total treatment duration is 3 days. This is a single-arm, open-label, phase I\u002FIIa proof-of-concept safety exploratory trial. Participants will be followed for 3 months post-FMT to assess safety, feasibility, and preliminary biological signals of immune recovery.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"xiaojin Wu, M.D., Ph.D.","CONTACT","+86-051267976360","wuxiaojin@suda.edu.cn",[28],{"facility":5,"status":20,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Suzhou","Jiangsu","215006","China","CN",{"type":35,"coordinates":36},"Point",[37,38],120.59538,31.30408,{"lat":38,"lon":37},[41],{"name":23,"role":24,"phone":42,"phoneExt":20,"email":26},"0512-63736361",{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100650978","safety-and-feasibility-of-fmt-for-immune-recovery-after-hsct-100650978",false,"NCT07755319","Safety and Feasibility of FMT for Immune Recovery After HSCT","Safety and Feasibility of Selective Fecal Microbiota Transplantation (FMT) for Immune Reconstitution in Immunodeficient Patients After Hematopoietic Stem Cell Transplantation (HSCT)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Receiving first allogeneic hematopoietic stem cell transplantation (allo-HSCT) with myeloablative or reduced-intensity conditioning\n* Able to complete scheduled follow-up visits and sample collections\n* Willing and able to provide written informed consent\n\nFor Phase 2 (FMT intervention): participants must additionally meet all of the following criteria at 6 months post-transplant:\n\n* Serum IgA \\\u003C 0.07 g\u002FL with IgG and IgM not yet recovered to normal range\n* No active grade III-IV acute graft-versus-host disease (GVHD)\n* Off systemic antibiotics for at least 2 weeks\n* Willing to receive fecal microbiota transplantation (FMT) and sign dedicated informed consent for the intervention\n\nExclusion Criteria:\n\n* Early post-transplant death or loss to follow-up\n* Active grade III-IV acute GVHD (at time of screening)\n* Continuous use of high-dose immunosuppressants (prednisone-equivalent dose \\> 1 mg\u002Fkg\u002Fday)\n* Refusal to participate or inability to comply with study procedures\n\nFor Phase 2 (FMT intervention): participants meeting any of the following criteria will be excluded from the FMT phase:\n\n* Gastrointestinal obstruction, perforation, or severe intestinal dysfunction\n* Severe cardiac, hepatic, or renal insufficiency that would preclude safe FMT administration\n* Known allergy or hypersensitivity to any component of the FMT preparation","ALL","18 Years",{"count":55,"type":56},86,"ESTIMATED","INTERVENTIONAL",[59,60],"PHASE1","PHASE2","Patients who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) often experience slow and incomplete recovery of their immune system, particularly the part responsible for producing antibodies (humoral immunity). This can lead to increased risk of infections and other complications. Previous studies suggest that the gut microbiome and its metabolites, such as short-chain fatty acids (propionate and butyrate), play a critical role in immune recovery.\n\nThis study has two phases. In the first phase, we will observe changes in immune function, lymphocyte subsets, and gut metabolites (propionate and butyrate) before and at 1, 3, and 6 months after transplantation in 50-80 patients. We will compare patients with severe immune deficiency to those with normal recovery to identify differences in gut bacteria and metabolites.\n\nIn the second phase, we will perform selective fecal microbiota transplantation (FMT) in 6 patients who still have severe humoral immunodeficiency at 6 months post-transplant. The FMT capsules will be specially selected from donors whose gut bacteria are rich in both propionate-producing and butyrate-producing strains. Patients will receive 20 capsules daily for 3 consecutive days (60 capsules total). We will evaluate the safety and feasibility of this approach, and observe whether fecal secretory immunoglobulin A (sIgA) shows signs of recovery at 3 months after FMT.\n\nThe study is expected to take approximately 2 years to complete. Findings may provide a new precision microbiome-based strategy to promote immune recovery after transplantation.",[63,64],"Humoral Immunodeficiency","Hematopoietic Stem Cell Transplantation","NOT_YET_RECRUITING","2026-08-08",{"date":68,"type":69},"2026-08-12","ACTUAL",{"date":71,"type":56},"2026-08-01",{"date":73,"type":56},"2028-10-31",{"name":5,"class":6},1]