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RecruitingNot ApplicableNCT05742074

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

The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers - a Multicentre, Randomized, Double-blinded and Placebo-controlled Study

Sponsor

Hvidovre University Hospital

Enrollment

80 participants

Start Date

Mar 24, 2023

Study Type

INTERVENTIONAL

Conditions

Faecal Microbiota TransplantationMultidrug Resistant Organisms

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

Min Age: 18 YearsMax Age: 110 Years

Inclusion Criteria4

  • Age: minimum 18 years
  • Positive rectal PCR and/or culture for MRO
  • Ability to speak and understand Danish or English
  • Capable of swallowing the capsules

Exclusion Criteria9

  • 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/mm3
  • Pancreatitis, defined by pancreatic amylases above the upper reference limit
  • Planned or recent abdominal surgery (within 14 days)
  • Parenteral nutrition
  • Current antibiotic treatment of the same MRO as intestinal carriage
  • Terminal disease with expected survival under three months
  • Sepsis defined according to Surviving Sepsis Campaign guidelines
  • Pregnant or lactating women

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Interventions

OTHERFaecal microbiota transplantation

25-30 capsules of faecal material

OTHERPlacebo

25-30 placebo capsules

Locations(1)

Hvidovre Hospital, Copenhagen University

Hvidovre, Copenhagen, Denmark

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NCT05742074

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