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Not Yet Recruiting NCT05742074

The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers

Conditions: Multidrug Resistant Organisms, Faecal Microbiota Transplantation

Sex: All
Ages: 18 Years – 110 Years
Phase: NA
Enrollment: 80
Sponsor: Hvidovre University Hospital

Location: Denmark

Summary

The aim of this study is to investigate the effect of faecal microbiota transplantation (FMT) on eradication of multidrug resistant organisms (MRO) in the intestine. Ultimately, it would be possible to prevent invasive infections with MRO that are difficult to treat and require last-resort antibiotics. The investigators hypothesize that FMT induce intestinal resistance towards colonization with MRO e.g. Vancomycin resistant Enterococcus Faecium (VRE), carbapenemase-producing Enterobacterales (CPE) and extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E).

Eligibility Criteria

Inclusion Criteria:Age: minimum 18 yearsPositive rectal PCR and/or culture for MROAbility to speak and understand Danish or EnglishCapable of swallowing the capsulesExclusion Criteria:Current invasive infection with an MRO e.g. in abdomen, bloodstream or symptomatic urinary tract infection.Severe immune deficiency (defined as current chemo treatment or neurofilocytes < 1000/mm3Pancreatitis, defined by pancreatic amylases above the upper reference limitPlanned or recent abdominal surgery (within 14 days)Parenteral nutritionCurrent antibiotic treatment of the same MRO as intestinal carriageTerminal disease with expected survival under three monthsSepsis defined according to Surviving Sepsis Campaign guidelinesPregnant or lactating women

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05742074). StuddyBuddy aggregates publicly available trial information.