human fecal microbiota
Trade name: Rebyota
Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Nov 30, 2022
Fecal microbiota transplant (FMT), also known as a stool transplant, is the process of transferring fecal bacteria and other microbes from a healthy individual into another individual. FMT is an effective treatment for Clostridioides difficile infection (CDI). For recurrent CDI, FMT is more effective than vancomycin alone, and may improve the outcome after the first index infection. — Wikipedia
Clinical trial activity
470 trials · 328 clinical orgs · 1 marketing orgs
Phase 1
146
Phase 2
192
Phase 3
50
Phase 4
4
Earliest trial started Oct 1, 2010 (NCT01226992)
Timeline
Indications
Approved for
Studied for
- Abdominal Injuries · Phase 2
- Aging · Early Phase 1
- Alcoholism · Phase 1/Phase 2
- Alopecia · Phase 2
- Alopecia Areata · Phase 2
- Alzheimer Disease · Phase 1
- Amyotrophic Lateral Sclerosis · Phase 1/Phase 2
- Anorexia Nervosa · Early Phase 1
- Anxiety · Phase 1/Phase 2
- Arthritis · Phase 2
- Arthritis, Gouty · Phase 2
- Arthritis, Psoriatic · Phase 2
- Arthritis, Reactive · Phase 2
- Arthritis, Rheumatoid · Phase 2
- Asymptomatic Infections · Phase 1/Phase 2
- Atherosclerosis · Phase 1
- Autism Spectrum Disorder · Phase 2
- Autistic Disorder · Phase 1
- Autoimmune Diseases · Phase 2
- Axial Spondyloarthritis · Phase 2
- Bacteria · Phase 2/Phase 3
- Bacterial Infections · Phase 2/Phase 3
- Bariatric Surgery · Phase 3
- Bipolar Disorder · Phase 2/Phase 3
- Bone Marrow Transplantation · Early Phase 1
- Carcinoma, Hepatocellular · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Pancreatic Ductal · Phase 1
- Carcinoma, Renal Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 2
- Cholangitis, Sclerosing · Phase 2
- Clostridioides difficile · Phase 3
- Clostridium Infections · Phase 3
- Cognition · Phase 2
- Cognitive Dysfunction · Phase 1/Phase 2
- Colitis · Phase 2
- Colitis, Microscopic · Early Phase 1
- Colitis, Ulcerative · Phase 4
- Colonic Neoplasms · Phase 2
- Colonoscopy · Phase 3
- Colorectal Neoplasms · Phase 2
- Constipation · Phase 3
- COVID-19 · Phase 3
- Crohn Disease · Phase 3
- Depression · Phase 2/Phase 3
- Depressive Disorder, Treatment-Resistant · Phase 2/Phase 3
- Dermatitis · Phase 2
- Dermatitis, Atopic · Early Phase 1
- Diabetes Insipidus · Phase 2
- Diabetes Mellitus · Phase 1/Phase 2
- Diabetes Mellitus, Type 2 · Phase 3
- Diarrhea · Phase 2
- Digestion · Early Phase 1
- Diverticular Diseases · Early Phase 1
- Diverticulitis · Phase 2
- Drug Resistance, Bacterial · Phase 2/Phase 3
- Drug Resistance, Multiple · Phase 2
- Dysbiosis · Phase 2
- Enterobacteriaceae Infections · Phase 3
- Enterocolitis · Phase 2
- Enterocolitis, Necrotizing · Early Phase 1
- Enterocolitis, Pseudomembranous · Phase 2
- Epilepsy · Phase 2/Phase 3
- Fatigue Syndrome, Chronic · Phase 2
- Fecal Incontinence · Phase 1/Phase 2
- Fecal Microbiota Transplantation · Phase 3
- Feces · Phase 4
- Fibromyalgia · Phase 2
- Fibrosis · Phase 1/Phase 2
- Frailty · Early Phase 1
- Gastrointestinal Diseases · Phase 2
- Gastrointestinal Microbiome · Phase 4
- Gastrointestinal Motility · Phase 1
- Glomerulonephritis, IGA · Phase 2
- Graft vs Host Disease · Phase 3
- Helicobacter pylori · Phase 1/Phase 2
- Hematopoietic Stem Cell Transplantation · Phase 2
- Hepatic Encephalopathy · Phase 2
- Hepatitis, Alcoholic · Phase 3
- Hidradenitis Suppurativa · Phase 2
- HIV · Phase 1
- HIV Infections · Phase 2
- Hodgkin Disease · Phase 2
- Hypertension · Phase 1/Phase 2
- Immunotherapy · Phase 2
- Infections · Phase 3
- Inflammation · Phase 1/Phase 2
- Inflammatory Bowel Diseases · Phase 2/Phase 3
- Insulin Resistance · Phase 2
- Intellectual Disability · Phase 2
- Intensive Care Units · Phase 2
- Intestinal Diseases · Phase 1/Phase 2
- Intestinal Neoplasms · Phase 2/Phase 3
- Irritable Bowel Syndrome · Phase 3
- Joint Diseases · Phase 2
- Kidney Diseases · Early Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Liver Cirrhosis · Phase 3
- Liver Diseases · Phase 1/Phase 2
- Liver Neoplasms · Phase 2
- Lung Neoplasms · Phase 2
- Lymphoma · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Major Depressive Disorder · Phase 2/Phase 3
- Malnutrition · Phase 1/Phase 2
- Melanoma · Phase 2
- Metabolic Diseases · Early Phase 1
- Metabolic Syndrome · Phase 2
- Microbiota · Phase 2/Phase 3
- Microsatellite Instability · Phase 2
- Multiple Myeloma · Phase 2
- Multiple Sclerosis · Phase 2
- Multiple Sclerosis, Relapsing-Remitting · Phase 1
- Muscles · Phase 2
- Musculoskeletal Diseases · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Myeloproliferative Disorders · Phase 2
- Nasopharyngeal Carcinoma · Phase 3
- Neoplasms · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 4
- Obesity · Phase 2
- Obesity, Metabolically Benign · Phase 1
- Obesity, Morbid · Phase 2
- Obsessive-Compulsive Disorder · Phase 2
- Pancreatic Neoplasms · Early Phase 1
- Pancreatitis · Phase 1/Phase 2
- Parkinson Disease · Phase 1/Phase 2
- Peanut Hypersensitivity · Phase 1
- Peritonitis · Phase 4
- Pouchitis · Phase 3
- Prediabetic State · Phase 2
- Proctitis · Phase 2
- Proctocolectomy, Restorative · Phase 2
- Prostatic Neoplasms · Phase 2
- Psoriasis · Phase 2
- Pulmonary Arterial Hypertension · Phase 1
- Respiratory Tract Neoplasms · Phase 2
- Sarcoidosis, Pulmonary · Phase 2
- Severe Acute Malnutrition · Phase 1/Phase 2
- Sjogren's Syndrome · Phase 1
- Sleep Initiation and Maintenance Disorders · Phase 1/Phase 2
- Sleep Wake Disorders · Phase 1/Phase 2
- Small Cell Lung Carcinoma · Phase 2
- Spinal Diseases · Phase 2
- Spondylitis · Phase 2
- Spondylitis, Ankylosing · Phase 2
- Sprains and Strains · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Stem Cells · Phase 2
- Stomach Neoplasms · Phase 2
- Tourette Syndrome · Phase 1/Phase 2
- Ulcer · Phase 1
- Urinary Tract Infections · Phase 2/Phase 3
Mechanism of action
- microbiotaTissue restoration
microbiota tissue restoration
Approval history
- approvedBreakthroughNov 30, 2022
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFecal microbiota transplant ↗
- NCATSQ805XO2F7C ↗
Also known as
- faecal microbiota
- fecal microbiome
- fecal microbiota
- fecal microbiota transplantation
- fecal microiota
- human fecal material
- human fecal microbiota
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07247786 | Phase 2 | Mar 15, 2026 | Fundación GECP, Grupo Español de Cáncer de Pulmón |
| NCT07292142 | Phase 1/Phase 2 (Phase 2) | Feb 28, 2026 | McGill University |
| NCT07276100 | Phase 2 | Jan 1, 2026 | University of Bologna |
| NCT07265817 | N/A | Dec 1, 2025 | Kyungpook University |
| NCT07017946 | Phase 1/Phase 2 (Phase 2) | Nov 1, 2025 | Duke University, University of Minnesota |
| NCT07120490 | N/A | Oct 31, 2025 | Medical University of Warsaw |
| NCT07172191 | N/A | Oct 1, 2025 | Del-Pest Central Hospital |
| NCT06801665 | Phase 2 | Sep 15, 2025 | Changzhou No.2 People's Hospital |
| NCT06948461 | Phase 2 | Sep 1, 2025 | PharmaPlanter Technologies Inc |
| NCT07106580 | Phase 1/Phase 2 (Phase 2) | Jul 28, 2025 | University Hospital, Rijeka |
| NCT07003438 | Early Phase 1 (Phase 1) | Jun 1, 2025 | Jiao Tong University |
| NCT06992453 | N/A | Jun 1, 2025 | Catholic University of Sacred Heart, Rome |
| NCT06827977 | Phase 2 | Apr 2, 2025 | University of Texas at Houston |
| NCT06890650 | N/A | Mar 15, 2025 | All India Institute of Medical Sciences, Banaras Hindu University, Dayanand Medical College, Indian Council of Medical Research, Indraprastha Institute of Information Technology Delhi, Lisie Hospital, Lokmanya Tilak Municipal Medical College, Postgraduate Institute of Medical Education and Research |
| NCT06906445 | N/A | Mar 15, 2025 | All India Institute of Medical Sciences |
| NCT06895252 | N/A | Mar 15, 2025 | All India Institute of Medical Sciences, Banaras Hindu University, Dayanand Medical College, Indian Council of Medical Research, Indraprastha Institute of Information Technology Delhi, Lisie Hospital, Lokmanya Tilak Municipal Medical College, Postgraduate Institute of Medical Education and Research |
| NCT06890637 | N/A | Mar 15, 2025 | All India Institute of Medical Sciences |
| NCT06776029 | Phase 2 | Feb 1, 2025 | Sun Yat-Sen University |
| NCT06692179 | Phase 1 | Jan 15, 2025 | University of Minnesota |
| NCT06744751 | N/A | Jan 1, 2025 | Jiao Tong University |
Showing 20 of 470 trials
Page 1 / 24
Organizations
Research & Development (328)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Harvard University | Academic/Hospital | 20 | 20 | 2 | 2012 |
| University of Helsinki | Academic/Hospital | 15 | 9 | 4 | 2015 |
| University of Texas at Houston | Academic/Hospital | 14 | 14 | 3 | 2013 |
| OpenBiome | Academic/Hospital | 13 | 3 | 3 | 2015 |
| Tel Aviv University | Academic/Hospital | 13 | 11 | 3 | 2015 |
| University of Alberta | Academic/Hospital | 13 | 12 | 3 | 2014 |
| University of Minnesota | Academic/Hospital | 12 | 9 | 2 | 2014 |
| University of Western Ontario | Academic/Hospital | 12 | 8 | 3 | 2012 |
| Institute of Liver and Biliary Sciences, India | Academic/Hospital | 11 | 11 | 1 | 2014 |
| McMaster University | Academic/Hospital | 11 | 8 | 4 | 2012 |
| People's Liberation Army of China | Government | 11 | 7 | 5 | 2012 |
| University of Copenhagen | Academic/Hospital | 10 | 8 | 4 | 2016 |
| Nanjing Medical University | Academic/Hospital | 9 | 9 | 4 | 2012 |
| Hebrew University | Academic/Hospital | 8 | 6 | 2 | 2013 |
| Jiao Tong University | Academic/Hospital | 8 | 8 | 4 | 2015 |
| University of Toronto | Academic/Hospital | 8 | 6 | 4 | 2010 |
| Aarhus University | Academic/Hospital | 7 | 5 | 3 | 2016 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 7 | 7 | 3 | 2014 |
| Department of Veteran Affairs | Government | 7 | 5 | 3 | 2013 |
| Government of Finland | Government | 7 | 3 | 1 | 2015 |
328 organizations
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