[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464587":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":42,"locations":52,"responsibleParty":75,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":32,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":32,"studyType":94,"phases":95,"briefSummary":98,"conditions":99,"keywords":32,"overallStatus":55,"whyStopped":32,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo FMT capsules","PLACEBO_COMPARATOR","Glycerol and saline solution will be pipetted into commercially available acid-resistant hypromellose capsules (DRCaps, Capsugel) (650 μL), which will be closed and then secondarily sealed. Capsules will be stored frozen at -80°C (-112°F). Patients will swallow 30 frozen capsules on two consecutive days. Capsules look exactly the same as FMT capsules",[13],"Other: Placebo capsules",{"label":15,"type":16,"description":17,"interventionNames":18},"FMT capsules","EXPERIMENTAL","Fecal matter solution (feces, glycerol and saline solution) will be pipetted into commercially available acid-resistant hypromellose capsules (DRCaps, Capsugel) (650 μL), which will be closed and then secondarily sealed. Capsules will be stored frozen at -80°C (-112°F). Patients will swallow 30 frozen capsules on two consecutive days.",[19],"Biological: Fecal Microbial Transplant (FMT)",{"label":21,"type":22,"description":23,"interventionNames":24},"FMT enemas","ACTIVE_COMPARATOR","patients will evacuate the bowel prior to the procedure and will fast for 3 hours prior to the procedure . Patients will receive 80 ml of enema\u002F Fecal matter solution (feces(25 gr of stool , glycerol and saline solution) will be stored at 50 ml tubes frozen at -80°C (-112°F).",[25],"Biological: Auto Fecal Microbial Transplant (FMT) via enema",[27,33,38],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BIOLOGICAL","Fecal Microbial Transplant (FMT)","FMT through capsules- patients will evacuate the bowel with 1 liter of Meroken solution 12 hours prior to the procedure and will fast from food for 12 hours prior to the procedure. Patients will swallow 30 frozen capsules on two consecutive days.",[15],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"OTHER","Placebo capsules","Patients will evacuate the bowel with 1 liter of Meroken solution 12 hours prior to the procedure and will fast from food for 12 hours prior to the procedure. Patients will swallow 30 frozen placebo-capsules on two consecutive days.",[9],{"type":28,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"Auto Fecal Microbial Transplant (FMT) via enema","3.FMT through enema- patients will evacuate the bowel prior to the procedure and will fast for 3 hours prior to the procedure . Patients will receive 80 ml of enema. Enemas will be administered with the assistance of the study nurse. Patients will be asked to hold the enema content for at least 15 minutes.",[21],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":32,"email":47},"Nitsan Maharshak, MD","CONTACT","97227360384","nitsanm@tlvmc.gov.il",{"name":49,"role":45,"phone":50,"phoneExt":32,"email":51},"Rony Izhar, PHD","97237772613","ronyi@tlvmc.gov.il",[53],{"facility":54,"status":55,"city":56,"state":32,"zip":32,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center","RECRUITING","Tel Aviv","Israel","IL",{"type":60,"coordinates":61},"Point",[62,63],34.78057,32.08088,{"lat":63,"lon":62},[66,68,70,73],{"name":44,"role":45,"phone":67,"phoneExt":32,"email":47},"972-3-6947305",{"name":44,"role":69,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"name":71,"role":72,"phone":32,"phoneExt":32,"email":32},"Naomi Fliss Isakov, PhD","SUB_INVESTIGATOR",{"name":74,"role":72,"phone":32,"phoneExt":32,"email":32},"Nathaniel Aviv Cohen, MD",{"type":69,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Shmuel Kivity, MD","director, R&D department",[79],{"name":80,"class":34},"Weizmann Institute of Science","100464587","phase-1-auto-fecal-microbial-transplant-post-helicobacter-pylori-antibiotic-therapy-100464587",false,"NCT05329636","Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy","Fecal Auto-transplantation for Enteric Microbial Rehabilitation Post 14 Day Antibiotics Therapy Against Helicobacter Pylori Infection","Inclusion Criteria:\n\n* Age 18-70 years old\n* Positive H. pylori on either breath test or gastric biopsy\n* Patient is intended to receive antibiotics therapy for H. pylori eradication\n\nExclusion Criteria:\n\n* Severe systemic disease that may impact the microbiome. For example: heart disease, type two diabetes, chronic liver or kidney failure\n* Antibiotics therapy during the prior 2 months to enrollment\n* Planned to receive antibiotics within the upcoming 2 months (surgery etc) for reasons other than H. Pylori\n* Inability to complete the study protocol (swallow capsules or to hold enema content for at least 15 minutes)\n* Pregnancy\n* Inability to give informed consent","ALL","18 Years","70 Years",{"count":92,"type":93},30,"ESTIMATED","INTERVENTIONAL",[96,97],"PHASE1","PHASE2","Current guidelines mandate Helicobacter pylori (H. Pylori) eradication with 2-3 antibiotics for 14 days ,This may result in multiple side effects and in eradication of important bacterial species to human health, exposing humans to multiple disease conditions.\n\nPreservation of fecal microbiome prior to antibiotic therapy and auto-transplantation of the microbes post H. pylori eradication, will enable avoiding eradication of beneficial microbial populations and perhaps protect from consequent disease conditions.",[100],"Helicobacter Pylori Infection","2024-07-03",{"date":103,"type":104},"2024-07-08","ACTUAL",{"date":106,"type":104},"2018-09-26",{"date":108,"type":93},"2026-07-01",{"name":5,"class":6},1]