Prevention of Recurrent Clostridium Difficile Infection in Inflammatory Bowel Disease

STUDY BASICS

Do you have inflammatory bowel disease (IBD) such as ulcerative colitis or Crohn’s disease? Are you currently being treated with antibiotics for Clostridium difficile (C. diff) infection? You may be able to participate in a research study to help find out if a drug used for the prevention of C. diff works to break the cycle of the infection in people with IBD. Compensation provided.

STUDY PURPOSE

Infection with Clostridium difficile (also known as C. diff) is common in people who have inflammatory bowel disease (IBD) such as ulcerative colitis and Crohn’s disease. Symptoms of C. diff can include mild to severe stomach cramps, diarrhea, nausea, and fever. Although treatments exist for C. diff, many people with IBD experience repeated bouts of the infection.

 

The purpose of this research study is to find out if a drug called bezlotoxumab (brand name Zinplava^TM) can stop the effects of current C. diff infection and reduce or prevent future recurrences of the infection in people with IBD who are taking an antibiotic for active C. diff infection. Bezlotoxumab is a manmade antibody that works with the body’s immune system to block C. diff. Bezlotoxumab is FDA-approved to treat C. diff in the general population but has not been tested in people with IBD.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• Currently being treated with antibiotics for Clostridium difficile (C. diff) infection
• Have inflammatory bowel disease (IBD) such as ulcerative colitis or Crohn’s disease
• No history of colectomy (surgical bowel resection)
• No history of congestive heart failure
• Not pregnant or breastfeeding

WHAT PARTICIPANTS CAN EXPECT

Study participation involves one in-person visit and three follow-up visits that may be done during regularly scheduled appointments or over the phone. During the first visit, participants will have a bezlotoxumab infusion administered in combination with standard-of-care antibiotic therapy. The bezlotoxumab administration is a one-time infusion (through a vein in the arm).