@article{Pitashny:2024:10.12688/openreseurope.16825.1,
author = {Pitashny, M and Kao, D and Ianiro, G and Mullish, B and Nagy, G and Urbonas, T and Kesten, I and Stabholz, Y and Kupcinskas, J and Franz, R and Rondinella, D and Tamburini, S and Tudlik, Z and Masucci, L and Quaranta, G and Fusco, W and Cammarota, G and Skieceviciene, J and Wong, K and Segata, N and Paul, M and Bar-Yoseph, H},
doi = {10.12688/openreseurope.16825.1},
journal = {Open Research Europe},
pages = {61--61},
title = {Lyophilized fecal microbiome transfer for primary Clostridioides difficile infection: a multicenter randomized controlled trial (DONATE Study)},
url = {http://dx.doi.org/10.12688/openreseurope.16825.1},
volume = {4},
year = {2024}
}

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TY  - JOUR
AB  - <ns3:p>Background Primary Clostridioides difficile infection (pCDI) carries high recurrence and mortality rates and is globally spread. pCDI is often a consequence of exposure to antibiotics, disrupting the healthy intestinal microbiota composition. Not surprisingly, in this antibiotic-associated infection, failure of the standard antibiotic treatment is high. Frozen fecal microbiota transplantation (FMT), the introduction of the microbial community from a healthy donor, has been shown to be safe and highly effective in cases of recurrent CDI, reaching >90% cumulative success rate. Importantly, FMT has shown potential for intestinal decolonization of multidrug-resistant organisms (MDRO), and/or mitigation of their ability to cause invasive infection. The use of FMT for pCDI, has been tested in small studies, showing promising results. The use of frozen FMT graft is often administered via colonoscopy or enteral (naso-jejunal) tubes, which are invasive procedures, placing significant burden on these often frail patients and the institutions providing the services. Moreover, frozen FMT is hampered by storage needs which limit accessibility and spread. Methods We have developed a lyophilized FMT product (Lyo-FMT - a dry compound that does not need freezing) that retains viability, prolongs the shelf time of the product and improves patient acceptance. In a randomized controlled multicenter trial, we aim to assess the efficacy of Lyo-FMT for pCDI in comparison to standard antibiotic therapy. Expected results This easy-to-administer product will restore the microbial community, fight the infective agent and reduce the overall antibiotic-resistant gene burden. This, in turn, will lower the recurrence rate and decrease carriage of other MDRO, coupled with a reduction in antibiotic use. Data on microbial shifts during treatment will shed light on our understanding of the pathophysiology of the disease. Clinicaltrials.gov registration <ns3:bold>NCT05709184
AU  - Pitashny,M
AU  - Kao,D
AU  - Ianiro,G
AU  - Mullish,B
AU  - Nagy,G
AU  - Urbonas,T
AU  - Kesten,I
AU  - Stabholz,Y
AU  - Kupcinskas,J
AU  - Franz,R
AU  - Rondinella,D
AU  - Tamburini,S
AU  - Tudlik,Z
AU  - Masucci,L
AU  - Quaranta,G
AU  - Fusco,W
AU  - Cammarota,G
AU  - Skieceviciene,J
AU  - Wong,K
AU  - Segata,N
AU  - Paul,M
AU  - Bar-Yoseph,H
DO  - 10.12688/openreseurope.16825.1
EP  - 61
PY  - 2024///
SP  - 61
TI  - Lyophilized fecal microbiome transfer for primary Clostridioides difficile infection: a multicenter randomized controlled trial (DONATE Study)
T2  - Open Research Europe
UR  - http://dx.doi.org/10.12688/openreseurope.16825.1
VL  - 4
ER  - 

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