Fecal Microbiota Transplant for Relapsing C. difficile Infection

There has been an alarming increase in the incidence and severity of Clostridium difficile infection (CDI) in North America over the past decade. Relapsing infection is a common problem in patients treated for CDI, often requiring prolonged and expensive courses of oral vancomycin with limited alternative treatment options.

This study will determine if fecal microbiota transplantation, which involves administering fecal flora from a healthy stool donor to a patient with relapsing CDI, is an effective and safe treatment.

Who is eligible?
Adult outpatients (men or women) between 18 and 74 years of age who:

• have suffered from at least a third or further recurrence of C. difficile infection and either failed a tapering course of vancomycin or are unable to taper or stop vancomycin without developing diarrhea requiring anti-infective therapy
• are willing to undergo fecal transplantation and submit to close follow-up for a period of eight weeks
• do not have inflammatory bowel disease (IBD)
• do not have an inherited or acquired immunodeficiency or taking immunosuppressant medications

What does participation involve?

• This is a randomized, double-blind study.
• Subjects will undergo a colonoscopy and receive fecal transplantation using stool from a healthy donor or a sham transplant (reinfusion with his/her own stool).
• Subjects may choose their own donor (friend or family member) or receive stool from a healthy volunteer.
• Sham treated subjects who relapse will have the option of being treated with donor stool in an open-label study.
• Subjects will be contacted regularly (via telephone), have follow-up office visits and be asked to keep a symptom diary.

To start the eligibility screening process or for more information, please contact:
Allison Tisch at 401-793-7240.