Clinical Trials at Englewood Hospital: Gastroenterology
- Please scroll down to view all studies -
EHMC IRB Study #:E-13-507
Dr. Marc Fiorillo
Expanded Access to Fecal Microbiota Transplantation (FMT) for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)
Patients who are at least 18 years old with a diagnosis of recurrent or relapsing Clostridium difficile infection
Once consented, the diagnostic angiogram must reveal one or two de novo lesions of appropriate size to continue on to randomization in the study.
To provide treatment with Fecal Microbiota Transplantation (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI).
Patients and potential donors will undergo a battery of screening tests. If both are eligible for FMT, the investigator will infuse stool from the healthy donor into the bowel of the patient with CDI. The method of administration will be up to the investigator, but can be done via a routine colonoscopy, sigmoidoscopy, or retained enema. Follow up monitoring will be performed to assess the efficacy of the treatment and to capture any adverse events. Repeat FMT may be offered.
EHMC IRB Study #: E-12-463
Dr. Mitchell Spinnell
A Randomized, Double-Blind, Active-Controlled Study of CB-183,315 in Patients with Clostridium Difficile Associated Diarrhea (CDAD)
Patients who are at least 18 years old with a diagnosis of Clostridium Difficile Associated Bacteria
To demonstrate the non-inferiority of CB-183,315 in comparison to vancomycin in adult subjects with CDAD
Patients will be randomized 1:1 to receive either oral vancomycin or oral CB-183,315 for 10 days. The study is blinded so that neither the physician nor patient knows which treatment has been assigned. Patients will have follow up clinic visits 2 days after the last dose, two weeks after the last dose, and one month after the last dose, and follow up phone calls in between those visits.