C. diff Clinical Trials

C. difficile in the Healthcare Setting

Clostridium difficile (C. difficile) is a pathogen of major public health importance and the most common cause of healthcare-associated diarrhea, with high rates of recurrent disease.  Over one third of patients who develop CDI will develop one or more recurrences and the risk of subsequent recurrence increases with each episode.

Through our clinical trials we aim to prevent and reduce the recurrence of C. difficile in our patients and subsequently reduce the burden it has both financially and physically for those that have been affected.

This study is for solid organ transplant recipients who have a recurrence of C. diff infection after their transplant. Organ transplant recipients may take medications that can disrupt normal gut bacteria, such as immunosuppressant drugs and antibiotics. As a result, organ transplant recipients have high rates of C. diff infection.

Participants will be asked to complete up to 7 study visits over approximately 30 weeks. Participants will be assigned to one of two groups, the fecal microbiota transplant group or the vancomycin group.

This study involves an investigational new drug that may prevent recurrent CDI like a fecal transplant.  This treatment is thought to prevent recurrent CDI by restoring the normal balance of microorganisms in the intestines by adding live, beneficial microorganisms.

The goal of Rebiotix is to prevent CDI infections from returning in people with recurrent CDI.

Participants  in this study will be followed by the study team for up to 9 months.  At a minimum, they will need to have 5 study visits during the study and have 5 telephone contacts. . Extra visits may be required if a CDI returns while someone is participating in the study.

The purpose of this research study is to compare the recurrence rate of C. diff and the composition of gut microbes (microorganisms that live in the digestive tracts in humans) in people treated with vancomycin compared to placebo.  We are doing this research because recurrences of CDI are common, difficult to treat, and pose significant threats to public health.

Participants in this trial would be asked to take oral vancomycin or placebo for the duration that they take an antibiotic for something unrelated to c. diff plus an additional 5 days after the antibiotic is completed.  In addition to taking the study drug, participants will be asked to participate in 3 visits as well as complete a stool diary for each day they are in the study.