If you’ve recently been diagnosed with or are being treated for C. diff and are considered at higher risk for experiencing a recurrent episode and you are 18 years or older, you may be eligible to participate in a study to investigate the safety and tolerability of an investigational drug called REC-3964.

What is recurrent C. Diff?  
C. diff is a bacterium that can infect the bowel and cause diarrhea. The standard treatment for an initial C. diff infection is antibiotics.  Although patients may initially respond to antibiotic treatment, 20-30% of patients will recur or get infection and diarrhea again. After the first recurrence of C. diff. (rCDI), there’s a 40% likelihood of a second recurrence, and a 45-65% likelihood of recurrence among patients who have recurred more than twice.

What is REC-3964?
REC-3964 is an investigational drug that has been shown to minimize the harmful effect of the C. difficile bacteria toxins on the colon in animal studies.  It is expected to help prevent C. difficile infections from recurring.

What is the ALDER trial?
The purpose of the ALDER trial is to investigate the safety, tolerability, pharmacokinetics and efficacy of REC-3964 for the reduction of recurrent CDI after initial cure with vancomycin.  Participants may receive treatment with REC-3964 for 28 days or be placed in an observation group.  

This is an open-label study, which means you will know which group you are placed in. The study will be conducted at several locations in the United States and will include about 80 participants divided into three groups. You have a 1 in 2 chance of being placed in the high dose group, and a 1 in 4 chance of being placed in either the lower dose group or the observation group (where you won’t receive REC-3964). The total study duration for each participant is up to 77 days.

If you are interested in participating, please visit clinicaltrials.gov and search for “REC-3964-201” or "ALDER. C. Diff"