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

Hvidovre University Hospital

Status: Enrolling

Conditions: Faecal Microbiota Transplantation; Multidrug Resistant Organisms

Treatments: Other: Placebo; Other: Faecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05742074

H-22040517

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

FMT (faecal microbiota transplantation)

Experimental group

Description:

25-30 capsules of faecal material.

Treatment:

Other: Faecal microbiota transplantation

Placebo

Placebo Comparator group

Description:

25-30 placebo capsules.

Treatment:

Other: Placebo