Project 467419

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

467419

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

$278,485
Project Information
Study Type: Unclear
Research Theme: Clinical
Institution & Funding
Principal Investigator(s): Kao, Dina H
Institution: University of Alberta Hospital (Edmonton)
CIHR Institute: Infection and Immunity
Program: Operating Grant: 14th JPIAMR transnational call for research projects (2022)
Peer Review Committee: Special Cases
Competition Year: 2022
Term: 3 yrs 0 mth
Abstract Summary

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.

No special research characteristics identified

This project does not include any of the advanced research characteristics tracked in our database.

Keywords
Clinical Trial Clostridioides Difficile Infection Fecal Transplant