Clostridium Difficile Infection Recurrence Clinical Trial
Official title:
Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.
Clostridium difficile (C.difficile) is a pathogen of major public health importance, especially in individuals with comorbid conditions such as solid organ transplantation (SOT). The incidence and adverse outcomes of CDI are greatly amplified in the setting of SOT, due to healthcare exposure, antibiotic use and immunosuppression, all of which are ubiquitous in SOT recipients. There are currently no effective treatment options to achieve a sustained cure of recurrent CDI and prevent further recurrence in SOT recipients. A novel approach that has recently gained attention is restoration of the CDI impaired gut microbiome by instillation of stool from a healthy donor into the intestine of a CDI patient. This treatment, called Fecal Microbiota Transplantation (FMT) has been found in non-comparative studies to reduce CDI recurrence dramatically with a reported efficacy of over 95%, however its efficacy in SOT recipients has not been studied and cannot be extrapolated from results in the non-SOT population because SOT recipients are a unique study population due to profound immunosuppression, frequent antibiotic use and frequent opportunities for exposure to CDI all of which markedly, repeatedly and persistently disrupt the gut microbiome. Thus, this critical gap in the field needs to be addressed by a trial of FMT in SOT recipients with CDI. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04000555 -
Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)
|
Phase 4 | |
| Terminated |
NCT03065374 -
Treatment for Clostridium-difficile Infection With IMM529
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05606159 -
Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections
|
N/A | |
| Completed |
NCT03110133 -
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
|
Phase 2 | |
| Recruiting |
NCT06237452 -
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
|
Phase 3 | |
| Completed |
NCT03880539 -
Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection
|
Phase 4 | |
| Not yet recruiting |
NCT04415918 -
Bezlotoxumab Efficacy and Tolerability in Cancer Patient
|
Phase 4 | |
| Recruiting |
NCT03562741 -
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
|
N/A | |
| Completed |
NCT03788434 -
Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
|
Phase 2 | |
| Completed |
NCT04891965 -
A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)
|
Phase 1 | |
| Completed |
NCT04317963 -
Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection
|
||
| Recruiting |
NCT05831189 -
A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
|
Phase 3 |