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Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
Sponsor: University Hospital, Ghent
Summary
Colonization by Multiple Drug Resistant Organisms (MDROs) during patient hospitalization requires expensive isolation measures and renders the return or transfer to other departments or institutions often impossible. Currently there is no specific treatment available. Patients have to wait for spontaneous clearance which can take months or does not happen at all. The study will test the effect of Fecal Microbiota Transfer (FMT) on gut MDRO colonization. The focus will be on patients with a long-term colonization by Gram-negative bacteria for which isolation is warranted. Participants will be randomized into two treatment groups; allogenic FMT versus autologous FMT. A third group of participants will be monitored but will not receive an FMT. Decolonization rate will be compared one month after treatment. Additionally gut microbial composition will be studied up to one year after FMT.
Official title: DEKODON: Decolonization of Gram-negative Multi-resistant Organisms (MDRO) with Donor Microbiota (FMT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2019-12-18
Completion Date
2025-12-30
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Allogenic FMT
Transplantation of fecal microbiota from a donor into a recipient
Autologous FMT
Transplantation of autologous fecal microbiota
Locations (1)
Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium