[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434327":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":32,"locations":38,"responsibleParty":278,"collaborators":280,"id":287,"slug":288,"hasResults":289,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":289,"sex":295,"minAge":296,"maxAge":18,"enrollmentInfo":297,"targetDuration":18,"studyType":300,"phases":301,"briefSummary":303,"conditions":304,"keywords":312,"overallStatus":81,"whyStopped":18,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Fecal Microbiota Transplantation (FMT)","EXPERIMENTAL","Patients randomized in the \"FMT group\" will received FMT. FMT product will be made by the the pharmacy of the Clermont-Ferrand University Hospital from stools of healthy volunteer donors within 6 hours after defecation in order to preserve the viability of the bacteria. The preparation will be standardized: 50g aliquots will be prepared and diluted in 250mL of 0.9% NaCl containing 10% glycerol, until a homogeneous suspension is obtained. The preparation will be rapidly frozen at -80°C until use, with a maximum shelf life of 18 months.",[13],"Drug: Fecal Microbiota Transplantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2: no intervention","NO_INTERVENTION","The comparator group will be constituted by patients randomized in the \"no FMT\" group. For ethical reasons, these patients will not receive any FMT and therefore no enema or colic preparation. No placebo will be administered. Prophylactic anti-infective treatments can be introduced at any time.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Fecal Microbiota Transplantation","Patients randomized in the \"FMT group\" will received FMT within 4 weeks following neutrophils recovery after the allo-HSCT procedure. The stool transplant will be done by enema. The day before FMT, patient will undergo bowel cleansing by ingestion of two liters of polyethylene glycol solution. The day of FMT, a colon cleanse enema will be performed in the morning and FMT will be delivered around two hours after the cleanse enema. This colic preparation is essential to optimize the results of FMT.\n\nThe enema (50g of stools diluted in 250mL of NaCl 0.9%) will be performed by a qualified member of the study team (nurse) by using a rectal cannula (within 6 hours of thawing). The enema will have to be kept by the patient for as long as possible and at least 30 minutes.",[9],[26,29],{"name":27,"affiliation":5,"role":28},"Jacques-Olivier BAY, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":28},"Stéphanie NGUYEN, MD, PhD","Groupe hospitalier Pitié-Salpêtrière, Paris",[33],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Lise LACLAUTRE","CONTACT","+33473754963","promo_interne_drci@chu-clermontferrand.fr",[39,55,67,79,92,104,116,128,140,152,164,176,188,201,210,219,231,242,254,266],{"facility":40,"status":41,"city":42,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud","NOT_YET_RECRUITING","Amiens","France","FR",{"type":46,"coordinates":47},"Point",[48,49],2.3,49.9,{"lat":49,"lon":48},[52,54],{"name":53,"role":35,"phone":18,"phoneExt":18,"email":18},"Magalie Magalie, MD",{"name":53,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":56,"status":41,"city":57,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Service Maladies du sang CHU Angers","Angers",{"type":46,"coordinates":59},[60,61],-0.55202,47.47156,{"lat":61,"lon":60},[64,66],{"name":65,"role":35,"phone":18,"phoneExt":18,"email":18},"Sylvie François, MD",{"name":65,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":68,"status":41,"city":69,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Hématologie clinique CHU Besançon","Besançon",{"type":46,"coordinates":71},[72,73],6.01815,47.24878,{"lat":73,"lon":72},[76,78],{"name":77,"role":35,"phone":18,"phoneExt":18,"email":18},"Etienne Daguindau, MD",{"name":77,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":80,"status":81,"city":82,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Plateforme d'Investigation Clinique \u002F Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand","RECRUITING","Clermont-Ferrand",{"type":46,"coordinates":84},[85,86],3.08682,45.77969,{"lat":86,"lon":85},[89,91],{"name":90,"role":35,"phone":18,"phoneExt":18,"email":18},"Christian Dualé, MD, PhD",{"name":90,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":93,"status":41,"city":82,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand",{"type":46,"coordinates":95},[85,86],{"lat":86,"lon":85},[98,100,101],{"name":99,"role":35,"phone":18,"phoneExt":18,"email":18},"Jacques-Olivier Bay, MD, PhD",{"name":99,"role":28,"phone":18,"phoneExt":18,"email":18},{"name":102,"role":103,"phone":18,"phoneExt":18,"email":18},"Aurélie Ravinet, MD","SUB_INVESTIGATOR",{"facility":105,"status":41,"city":106,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Service hématologie CHU Grenoble","Grenoble",{"type":46,"coordinates":108},[109,110],5.71479,45.17869,{"lat":110,"lon":109},[113,115],{"name":114,"role":35,"phone":18,"phoneExt":18,"email":18},"Claude-Eric Bulabois, MD",{"name":114,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":117,"status":41,"city":118,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille","Lille",{"type":46,"coordinates":120},[121,122],3.05512,50.63391,{"lat":122,"lon":121},[125,127],{"name":126,"role":35,"phone":18,"phoneExt":18,"email":18},"David Beauvais, MD",{"name":126,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":129,"status":41,"city":130,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges","Limoges",{"type":46,"coordinates":132},[133,134],1.24759,45.83362,{"lat":134,"lon":133},[137,139],{"name":138,"role":35,"phone":18,"phoneExt":18,"email":18},"Pascal Turlure, MD",{"name":138,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":141,"status":41,"city":142,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Service d'Hématologie Centre Hospitalier Lyon Sud","Lyon",{"type":46,"coordinates":144},[145,146],4.84789,45.74906,{"lat":146,"lon":145},[149,151],{"name":150,"role":35,"phone":18,"phoneExt":18,"email":18},"Marie-Virginie Larcher, MD",{"name":150,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":153,"status":41,"city":154,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy","Nancy",{"type":46,"coordinates":156},[157,158],6.18496,48.68439,{"lat":158,"lon":157},[161,163],{"name":162,"role":35,"phone":18,"phoneExt":18,"email":18},"Marie-Therese Rubio, MD",{"name":162,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":165,"status":41,"city":166,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Service d'Hématologie Clinique CHU Nantes","Nantes",{"type":46,"coordinates":168},[169,170],-1.55336,47.21725,{"lat":170,"lon":169},[173,175],{"name":174,"role":35,"phone":18,"phoneExt":18,"email":18},"Patrice Chevallier, MD",{"name":174,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":177,"status":41,"city":178,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Service d'hématologie clinique, département de greffe de moelle CHU Nice","Nice",{"type":46,"coordinates":180},[181,182],7.26608,43.70313,{"lat":182,"lon":181},[185,187],{"name":186,"role":35,"phone":18,"phoneExt":18,"email":18},"Michel Loschi, MD",{"name":186,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":189,"status":81,"city":190,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Service d'Hématologie Adultes Hôpital Necker","Paris",{"type":46,"coordinates":192},[193,194],2.3488,48.85341,{"lat":194,"lon":193},[197,199],{"name":198,"role":35,"phone":18,"phoneExt":18,"email":18},"felipe Suarez, PU-PH",{"name":200,"role":28,"phone":18,"phoneExt":18,"email":18},"Ambroise Marçais, MD",{"facility":202,"status":41,"city":190,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":203,"geoPoint":205,"contacts":206},"Service d'Hématologie clinique Hôpital Pitié-Salpêtrière",{"type":46,"coordinates":204},[193,194],{"lat":194,"lon":193},[207,209],{"name":208,"role":35,"phone":18,"phoneExt":18,"email":18},"Stéphanie Nguyen, MD, PhD",{"name":208,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":211,"status":41,"city":190,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":212,"geoPoint":214,"contacts":215},"Service d'hématologie greffe Hôpital St Louis",{"type":46,"coordinates":213},[193,194],{"lat":194,"lon":193},[216,218],{"name":217,"role":35,"phone":18,"phoneExt":18,"email":18},"Marie Robin, MD",{"name":217,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":220,"status":41,"city":221,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque","Pessac",{"type":46,"coordinates":223},[224,225],-0.6324,44.80565,{"lat":225,"lon":224},[228,230],{"name":229,"role":35,"phone":18,"phoneExt":18,"email":18},"Carmen Botella Garcia, MD",{"name":229,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":211,"status":41,"city":232,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Poitiers",{"type":46,"coordinates":234},[235,236],0.34348,46.58261,{"lat":236,"lon":235},[239,241],{"name":240,"role":35,"phone":18,"phoneExt":18,"email":18},"Deborah Desmier, MD",{"name":240,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":243,"status":41,"city":244,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Département d'hématologie CAC Rouen","Rouen",{"type":46,"coordinates":246},[247,248],1.09932,49.44313,{"lat":248,"lon":247},[251,253],{"name":252,"role":35,"phone":18,"phoneExt":18,"email":18},"Anne-Lise Menard, MD",{"name":252,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":255,"status":41,"city":256,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Hématologie clinique Institut de Cancérologie de la Loire","Saint-Etienne",{"type":46,"coordinates":258},[259,260],4.39,45.43389,{"lat":260,"lon":259},[263,265],{"name":264,"role":35,"phone":18,"phoneExt":18,"email":18},"Emmanuelle Tavernier, MD",{"name":264,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":267,"status":41,"city":268,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"IUC T - Oncopôle","Toulouse",{"type":46,"coordinates":270},[271,272],1.44367,43.60426,{"lat":272,"lon":271},[275,277],{"name":276,"role":35,"phone":18,"phoneExt":18,"email":18},"Anne Huynh, MD",{"name":276,"role":28,"phone":18,"phoneExt":18,"email":18},{"type":279,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[281,284],{"name":282,"class":283},"Ministry of Health, France","OTHER_GOV",{"name":285,"class":286},"French Society of Hematology","UNKNOWN","100434327","phase-2-faecal-microbiota-transplantation-after-allogeneic-stem-cell-transplantation-100434327",false,"NCT04935684","Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation","Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies","TMF-Allo","Inclusion Criteria:\n\n* Patient aged 18 or over\n* Men and women\n* Patients affiliated with a social-security organization\n* Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood)\n* Signed and dated informed consent\n\nExclusion Criteria:\n\n* Status of tumor progression at the time of allo-HSCT\n* Inability to understand the protocol (linguistic barrier, cognitive difficulties)\n* Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma)\n* Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis)\n* Fecal incontinence\n* Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of GvHD, or studying the effectiveness of a FMT in another indication.\n* Pregnant women\n* Patient under guardianship, curatorship or protection of justice","ALL","18 Years",{"count":298,"type":299},150,"ESTIMATED","INTERVENTIONAL",[302],"PHASE2","The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD).\n\nThe hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.",[305,306,307,308,309,310,311],"Acute Leukemia in Remission","Myelodysplastic Syndromes","Myeloproliferative Syndrome","Hodgkin Lymphoma","Lymphoma, Non-Hodgkin","Myeloma","Chronic Lymphocytic Leukemia",[313,314,315,316,317,22],"Allogeneic hematopoietic stem cell transplantation","Hematologic malignancies","Graft versus Host Disease","Intestinal microbiota","Intestinal dysbiosis","2026-06-08",{"date":320,"type":321},"2026-06-09","ACTUAL",{"date":323,"type":321},"2022-12-20",{"date":325,"type":299},"2030-05",{"name":5,"class":6},20]