Medical Services

Clinical Trials at Englewood Hospital: Gastroenterology

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EHMC IRB Study #:E-13-507

Principal Investigator: 
Dr. Marc Fiorillo
Tel: 201-945-6564
Email: fiorillomd@gmail.com

Study Coordinator: 
Rosy Cascina
Tel:
Email: rosabel.cascina@ehmc.com

Sponsor:
Internal

Study Title:
Expanded Access to Fecal Microbiota Transplantation (FMT) for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)

Eligibility requirements:
Patients who are at least 18 years old with a diagnosis of recurrent or relapsing Clostridium difficile infection.

Study objectives:
To provide treatment with Fecal Microbiota Transplantation (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI).

Procedures:
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.

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EHMC IRB Study #: E-12-463

Principal Investigator: 
Dr. Mitchell Spinnell
Tel: 201-945-6564
Email: mspinnell@gimeds.com

Study Coordinator: 
Sajjad Naqvi
Tel: 201-894-3917
Email: sajjadnaqvi25@gmail.com

Sponsor:
Cubist Pharmaceuticals

Study Title:
A Randomized, Double-Blind, Active-Controlled Study of CB-183,315 in Patients with Clostridium Difficile Associated Diarrhea (CDAD)

Eligibility requirements:
Patients who are at least 18 years old with a diagnosis of Clostridium Difficile Associated Bacteria

Study objectives:
To demonstrate the non-inferiority of CB-183,315 in comparison to vancomycin in adult subjects with CDAD

Procedures:
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.

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*Each listing only contains a summary of the study information. Please contact the Principal Investigator or Study Coordinator for the full details on a particular study.