8 completed, 1 terminated. 6 Phase 2, 3 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 5, Terminated 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy RBX7455, Placebo - Hepatic Encephalopathy, Cirrhosis, Liver | Phase 2 | Terminated | Ochsner Health System | 5 | 2021-03-01 | 2023-10-03 |
| Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) RBX2660 - Clostridium Difficile Infection, Infection | Phase 3 | Completed | Rebiotix Inc. | 793 | 2019-07-30 | 2024-08-07 |
| Fecal Microbiota Transplantation (FMT) for MDRO UTI Fecal microbiota transplant - Urinary Tract Infections | Phase 1 / Phase 2 | Completed | Washington University School of Medicine | 1 | 2018-02-08 | 2022-03-18 |
| Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3) RBX2660, Placebo, Open label RBX2660 (only for confirmed CDI recurrence) - Clostridium Difficile Infection (CDI) | Phase 3 | Completed | Rebiotix Inc. | 320 | 2017-07-31 | 2024-07-10 |
| Treatment of Recurrent Clostridium Difficile Infection With RBX7455 RBX7455 - Clostridium Difficile Infection | Phase 1 | Completed | Mayo Clinic | 30 | 2016-11-01 | 2020-12-08 |
| Fecal Transplant for Hepatic Encephalopathy FMT - Hepatic Encephalopathy | Phase 1 / Phase 2 | Completed | University of Alberta | 3 | 2016-04-12 | 2022-06-10 |
| Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection RBX2660, Standard of Care Antibiotics - Clostridium Difficile Infection | Phase 2 | Completed | Rebiotix Inc. | 272 | 2015-10-01 | 2021-03-26 |
| Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection RBX2660 (microbiota suspension), Placebo - Enterocolitis Clostridium Difficile Recurrent | Phase 2 | Completed | Rebiotix Inc. | 150 | 2014-12-01 | 2021-01-15 |
| Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea RBX2660 (microbiota suspension) - Recurrent Clostridium Difficile Infection | Phase 2 | Completed | Rebiotix Inc. | 34 | 2013-08-01 | 2019-11-13 |
Clostridium Infections (5) · Diarrhea (5) · Enterocolitis, Pseudomembranous (2) · Hepatic Encephalopathy (2) · Brain Diseases (1) · Communicable Diseases (1) · Infections (1) · Liver Cirrhosis (1) · Urinary Tract Infections (1)
Anti-Bacterial Agents (1) · Fecal Microbiota Transplantation (1) · Saline Solution (1) · Single Person (1)
United States (8) · Canada (5)
Teena Chopra, M.D., M.P.H. (2) · Arnab Ray, MD (1) · Dimitri Drekonja, MD (1) · Dina Kao, MD (1) · Erik Dubberke, MD, MSPH (1) · Julia Garcia-Diaz, MD (1) · Sahil Khanna (1) · Teena Chopra, MD MPH (1)
PMID 41245385, PMID 42286373, PMID 26565008, PMID 29617739, PMID 32862830, PMID 32966574, PMID 33593430, PMID 35279084, PMID 36287379, PMID 36544075, PMID 37564743, PMID 38109364, PMID 38236515, PMID 39006315, PMID 39172632, PMID 39180326, PMID 40177588, PMID 40552763, PMID 40672762, PMID 40784972, PMID 41115624, PMID 41653256, PMID 42840322