Clinical trial NCT05742074: The Effect of Faecal Microbiota Transplantation (FMT) on Eradication of Multidrug Resistant Organisms (MRO) in Intestinal Carriers
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multidrug Resistant Organisms
Faecal Microbiota Transplantation
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Odense University Hospital
name: Zealand University Hospital
First posted: 2023-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with MRO clearance
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of participants with MRO clearance
timeFrame: 16 weeks
measure: Number of participants with adverse events.
timeFrame: 8 weeks, 16 weeks and 6 months.
measure: Comparison of the frequency of invasive infections
timeFrame: 6 months
measure: Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group.
timeFrame: 6 months
measure: Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group.
timeFrame: 8 weeks and 16 weeks
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Copenhagen University
state: Copenhagen
Study officials:
References: