Oct 30, 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 FDA approved, 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.
Finch Therapeutics Group has developed an oral FMT in an encapsulated 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 is designed to contain 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 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 or preventing recurrent C. diff. It must go through several rounds of clinical research trials to 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. diff infections and meet certain other eligibility criteria.
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 more about the trial, visit prism3trial.com or clinicaltrials.gov (NCT03110133
Feb 14, 2017 Hi all. Catherine Duff here. Just wanted to say a quick word about the Foundation, as many have asked about updates to the website. We have been so busy attending meetings, answering questions, collaborating with other stakeholders, social media, interviews, committees, fundraising, and trying to keep up with the dizzying pace with which this field of study is rapidly expanding that the site has taken a backseat at times. But please know we are here and doing everything we can to fulfill our mission statement, and working to increase access to this amazing treatment. In other news, we would like to share that our good friends at Emory University, led by Dr. Colleen Kraft and Dr. Tanvi Dhere of the Microbiota Enrichment Program, are enrolling patients in an industry-sponsored research study looking at using the SERES Therapeutics spore pill to restore microbiota after the FIRST episode of C. difficile infection. Please email Dr. Colleen Kraft immediately (email@example.com) if you receive this diagnosis and start treatment. The spore pill is given as soon as the C. diff. treatment is completed. They are available for questions about the protocol when you email them. Dec 26, 2014 A possible alternative to antibiotics: http://m.phys.org/news/2014-11-alternative-antibiotics.html Dec 24, 2014 Can poop prevent diabetes? Find out more: http://m.startribune.com/lifestyle/health/284227581.html Dec 20, 2014 A great article about depression and disease in The Huffington Post: http://www.huffingtonpost.com/2014/12/02/depression-infectious-dis_n_6172074.html?ncid=fcbklnkushpmg00000063 Dec 19, 2014 Breakthrough: good gut bacteria ‘highly effective’ against malaria transmission: http://www.medicalnewstoday.com/articles/286283.php Dec 15, 2014 Want to find out more about the Human Food Project? Click on the link http://humanfoodproject.com to do just that Dec 12, 2014 Find out more about The Center for Microbiome Informatics and Therapeutics at http://imes.mit.edu/microbiome
Dec 5, 2014
Find out more about the poop pill: http://goo.gl/PRhpV1
Dec 3, 2014
Read about FMT in the management of active Crohn’s Disease: http://goo.gl/nxKmkC
Dec 1, 2014
Read about the difficulty of finding a healthy stool donor in Internal Medicine News: http://goo.gl/c7rTV1
Nov 6, 2014
MIT News: http://newsoffice.mit.edu/2014/new-mit-center-microbiome-and-human-health-1106
June 4, 2014 Genetic Engineering & Biotechnology News, by Marwa ElRakaiby, et. al., The Impact of Human Microbiome Variations on Systems Pharmacology and Customized Therapeutics June 3, 2014 UCSF, by Claire Conway, Culturing for Cures An article from today’s L.A. Times regarding FMT and donor stool banks: http://www.latimes.com/opinion/editorials/la-ed-fecal-transplant-20140305,0,830248.story#axzz2v6E9XwIl Check out this video from Dr. Elaine Hsaio from The Patterson Lab at Cal Tech for a basic understanding of the human microbiota system: http://www.youtube.com/watch?v=FWT_BLVOASI