C.Difficile Colitis Clinical Trial
Official title:
EGESTA - Emergent GI Therapy for Severe, Complicated CDI Using Fecal Microbiota
The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate
the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C.
difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota
transplant (FMT) can improve scCDI, with "improve" defined as either decreasing the severity
of CDI, or by resolving the infection altogether. Third, the study seeks to further study the
mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing
on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and
fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred
to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy
donors.
The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared
to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.
The objectives/specific aims of this study are three-fold. First, the study seeks to evaluate
the safety of fecal microbiota transplant (FMT) in patients with severe, complicated C.
difficile infection (scCDI). Second, the study seeks to evaluate whether fecal microbiota
transplant (FMT) can improve scCDI, with "improve" defined as either decreasing the severity
of CDI, or by resolving the infection altogether. Third, the study seeks to further study the
mechanism by which FMT improves the course of scCDI by performing 16S rRNA and ITS sequencing
on pre-FMT and serial post-FMT stool samples in order to measure changes to bacterial and
fungal microbiota as a consequence of CDI and FMT therapy. FMT material (hereafter referred
to as FMTm) would be obtained from OpenBiome. FMTm is prepared from prescreened healthy
donors.
The hypothesis of the study is that FMT is a preferred salvage therapy for scCDI as compared
to (1) ongoing, failing medical therapy with conventional antibiotics and (2) surgery.
The standard of care treatment for scCDI is conventional antibiotics with either
parenteral/oral metronidazole, and/or vancomycin provided in the form of oral and/or
retention enemas. The reliability of these conventional antibiotics in the setting of scCDI
is very unpredictable, and patients with CDI of this severity have a mortality rate that in
some series is greater than 50%. It is against the mediocre historical record of these
antibiotics that FMT would be tested in this highly moribund patient population.
FMT would not be provided to patients with scCDI off protocol.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03462459 -
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
|
Phase 2 |