September 26, 2018

C. diff in the News: New Clinical Trial Option

 

If you have had C. difficile (C.diff), you know this infection is isolating, debilitating, and sometimes life threatening. Also, C. diff can respond to treatment, but then return without warning. Recurrent C. diff is common, and currently, there is no effective, non-invasive method to prevent it.

One increasingly popular way to prevent recurrent C. diff is through a fecal microbiota transplant (FMT). Traditional FMT is administered as an enema or colonoscopy, which are both somewhat invasive methods. Further research is now ongoing to come up with more effective and easier ways to administer FMT to prevent C. diff from coming back.

One of our sponsors, Finch Therapeutics Group, has developed an oral FMT in a capsulated form, designed to deliver gut bacteria from healthy human donors to the intestine. This investigational drug, CP101, is being studied in a clinical research trial (PRISM 3) to see if it is safe and effective at preventing the recurrence of C. diff.

Like a traditional FMT, CP101 contains the full community of gut bacteria found in the stool of healthy human donors. Unlike a traditional FMT, CP101 is an odorless capsule taken by mouth. These capsules contain gut bacteria in the form of a freeze-dried powder. The capsule itself was carefully designed to dissolve in your intestine where the bacteria can repopulate in your gut.

CP101 is considered investigational because it has not been approved by the US Food and Drug Administration (FDA) or other regulatory authorities for treating orpreventing recurrent C. diff. It must go through several rounds of clinical research trialsto make sure it is safe and effective for public use.

You are not alone on your journey to fight recurrent C. diff. The PRISM 3 trial is open to adults 18 years of age and older who have experienced multiple C. diffinfections.

If you are eligible and decide to participate in the PRISM 3 study, you will be randomly assigned, with an equal chance, to receive a single dose of CP101 or placebo (no active ingredients). If you experience an episode of C. diff within 8 weeks of receiving study drug or placebo, you may be eligible to receive CP101 by participating in an optional extension study. Your participation in the study may last up to 6 months. What researchers learn from the PRISM 3 study may help other people with recurrent C. diff in the future.

The PRISM 3 study team is available to answer any questions you may have about study participation or CP101. The trial is being conducted in 27 states in the US and 2 providences in Canada. To find a site near you, or to learn moreabout the trial, visit prism3trial.com or clinicaltrials.gov.

There are also additional resources available for you through the Peggy Lillis Foundation, including tips for coping with C. diff and support from other C. diff survivors.

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