[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594323":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":52,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Duke University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MTP-101C administration","EXPERIMENTAL","MTP-101C is a freeze-dried encapsulated universal donor microbiome-based formulation. Participants will ingest 2 capsules daily for 3 days then 1 capsule daily. This is preceded by antibiotic conditioning with a combination of vancomycin and neomycin, followed by a bowel purgative with magnesium citrate depending upon underlying comorbidities.",[13],"Drug: MTP-101C",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","MTP-101C","MTP-101C is a freeze-dried encapsulated formulation of fecal microbiota purified from the stool of healthy donors.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Richard Bedlack, MD, PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","919-613-2681","ALSresearch@duke.edu",{"name":31,"role":27,"phone":28,"phoneExt":20,"email":29},"Michelle Ward, RN",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27705","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-78.89862,35.99403,{"lat":45,"lon":44},[48,50,51],{"name":49,"role":27,"phone":28,"phoneExt":20,"email":20},"Richard Bedlack, MD. PhD",{"name":20,"role":27,"phone":20,"phoneExt":20,"email":29},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[55],{"name":56,"class":6},"University of Minnesota","100594323","phase-1-intestinal-microbiome-transplant-in-als-100594323",false,"NCT07017946","Intestinal Microbiome Transplant in ALS","A Pilot Trial to Investigate the Safety and Efficacy of Intestinal Microbiome Transplant (MTT) in People With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n* Diagnosis of ALS according to Gold Coast Criteria\n* Age: 18+ years at enrollment\n* Fast-progressing (ALSFRS-R change of at least 1.5 points per month between last 2 measurements at screening)\n* Modestly but not severely affected (ALSFRS-R score at or above 24 at screening)\n* Able to swallow capsules and expected to be able to for the duration of the trial (ALSFRS-R \"swallowing\" score of 3 or 4 at screening)\n* Expected to survive for the duration of the trial\n* Taking any combination of riluzole, edaravone, and\u002For tofersen at a stable dose for 30 days prior to screening, or not taking any of these and not expected to during the study.\n* Capable of giving written consent.\n* If sexually active, must agree to use contraceptive or abstinence for duration of treatment.\n* Females of child-bearing age must have negative pregnancy test at screening.\n\nExclusion Criteria:\n\n* Concurrent illness or laboratory abnormalities that could confound the measurement of ALS progression or the microbiome or interfere with the ability to complete the study.\n* Taking probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening\n* Taking antibiotics within 3 months of screening.\n* Taking any investigational study drug within 30 days of screening or five half-lives of the prior agent.\n* Previous exposure to MTT.\n* Pregnancy.\n* Known specific food allergy with anaphylaxis\n* Other co-morbid conditions that, in the opinion of the study investigator, place the participant at increased risk of complications, interfere with study participation or compliance, or confound study objectives.","ALL","18 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","This is a 24-week study of intestinal microbiome transplant in people with ALS. All participants will be evaluated clinically in person for 4 visits. Blood and mailed\u002F fresh stool samples will also be collected. Blood samples will be used to determine changes in neurofilament light chain over time. Stool samples will be processed for microbiome analysis. Participants will have phone visits to further evaluate safety and tolerability. They will then undergo antibiotic conditioning and a standard bowel preparation before being assigned to the investigational product, MTP-101C .",[75],"Amyotrophic Lateral Sclerosis ALS","2026-04-10",{"date":78,"type":79},"2026-04-13","ACTUAL",{"date":81,"type":79},"2026-01-27",{"date":83,"type":68},"2026-11-01",{"name":5,"class":6},1]