Dr Allegretti reviews the key points of her presentation on new live and microbiome-based therapeutics for recurrent Clostridioides difficile among patients with inflammatory bowel disease.

Jessica Allegretti, MD, is an associate professor at Harvard Medical School and medical director of the Crohn's & Colitis Center and director of the fecal microbiota transplant program at Brigham and Women's Hospital in Boston, Massachusetts.

TRANSCRIPT:

Hi everyone, my name is Jessica Allegretti and I'm the medical director of the Crohn's and Colitis Center at the Brigham and Women's Hospital in Boston, Massachusetts. And I had the pleasure of discussing “Management of recurrent C difficile Infection in Patients With IBD: Ppdates in an Era of Live Biotherapeutic Products.” This was a symposium held at the Advances in IBD conference in Orlando this December, and I was joined by two incredible speakers, Jordan Axelrad and Benjamin Cohen. We had 3 different sections discussed. Dr. Axelrad discussed really an overview of C diff infection in patients with IBD Dr. Benjamin Cohen discussed antibiotics and bezlotoxumab, so sort of therapeutics in this space. And I had the pleasure of discussing microbiome therapeutics and the new live biotherapeutic products in this space to treat recurrent C diff infections in patients with IBD. And really what I touched on was fecal microbiota transplantation or FMT, which we are still doing in the United States under the FDA's policy of enforcement discretion. However, this is still not FDA approved. It is still considered experimental, and we really don't know if and when the FDA is going to rescind this policy.

That being said, we do have good evidence to support the use of FMT for the prevention of recurrent C diff in patients with inflammatory bowel disease. Our group conducted the largest prospective trial to date, the ICON trial, in which 15 patients were enrolled at 4 centers around the United States. Every patient got a colonoscopic-administered FMT, and we followed patients through 12 weeks to look at both C diff outcomes as well as IBD outcomes. And ultimately what we found is that only 8% of the patients in this trial experienced a true FMT failure or C diff recurrence, which is much lower than what had been previously reported, and we did not see any significant worsening of patients underlying IBD against supporting the safety and tolerability of this therapy in patients with inflammatory bowel disease.

I'm happy to report that we also recently finished the ICON 2 study in which we paired bezlotoxumab with FMT and we're going to be reporting data from this trial at an upcoming, hopefully at the upcoming DDW meeting. This however is a very exciting time to be practicing in this space because we now have 2 FDA approved novel live biotherapeutic products, one from Ferring, which is called Rebyota. This is a rectally administered product, and we also have Vowst from Seres Therapeutics and Nestlé Health, which is an oral product. Both of these products are approved for the prevention of recurrent C diff. Again, the enema-based or rectally administered product is meant to be done in clinic or in the hospital, and the oral product can be done at home. I would say there are definitely uses for both of these products in this space. It's good to have options because certainly there are patient preference and reasons why you might want an oral or a rectal product. None of these have been formally studied in patients with IBD yet, though we are going to see data I think emerging in the very near future. And so again, this is a very exciting time and we've got more products underway, so certainly stay tuned for some more exciting data to be coming out.