LyophilizeD fecal micrObiome traNsfer for primAry closTridioides difficilE infection (DONATE study): a multicenter randomized controlled trial (DONATE)


Primary Clostridioides difficile infection (pCDI) is a gastrointestinal infection that presents with diarrhea, fever and abdominal pain and is often resistant to antibiotic therapy. pCDI is often a consequence of previous exposure to antibiotics that disrupt the balance of healthy microbes that reside in our gut.

Fecal microbiota transplantation (FMT), the introduction of a healthy microbial community from a healthy donor, has been shown to be safe and highly effective in patients who experience recurrence of CDI, but was not vigorously tested in primary infection. FMT can also fight other deleterious microbes that might reside in the gut. Since FMT contains live bacteria, it needs to be kept frozen until administration.

We have developed a dry compound that does not need freezing (Lyo-FMT) and aim to assess its efficacy for pCDI. This easy-to-administer product will restore the healthy bacterial community, fight infection and reduce the use of antibiotics. If effective, this study will revolutionize the treatment of this worldwide distributed infection.

Project partners

  • Milena Pitashny, Rambam Health Care Campus, Israel (Coordinator)
  • Gianluca Ianiro, Fondazione Policlinico Universitario “A. Gemelli” IRCCS, Italy
  • Nicola Segata, European Institute of Oncology, Italy
  • Dina Kao, University of Alberta, Canada
  • Benjamin Mullish, Imperial College London, United Kingdom
  • Gergely Nagy, University of Debrecen, Hungary
  • Juozas Kupcinskas, Lithuanian University of Health Sciences, Lithuania