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

The study is designed as a randomized, double-blinded and placebo-controlled clinical trial. The participants (n = 80) will be randomized 1:1 to FMT or placebo. FMT or placebo consist of 25-30 capsules which need to be consumed on one day or alternatively consumed over three consecutive days, if one day is unacceptable to the participant. At baseline, eight weeks, and 16 weeks rectal swabs for PCR and culture will be taken. Regarding VRE and CPO, there are specific PCRs followed by confirmatory culture, whereas ESBL-E is detected by culture of rectal swab. Furthermore, participants will be asked to deliver faecal samples as well at baseline and 16 weeks post FMT to examine changes in the intestinal microbiome.

Inclusion criteria

• 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 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/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