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

N/ARecruitingNCT05742074

Hvidovre University Hospital80 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Multidrug Resistant Organisms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with MRO clearance

Number of participants with MRO clearance after eight weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The results from the test will be positive or negative.

Time frame: 8 weeks

Secondary Outcomes

Number of participants with MRO clearance

Number of participants with negative PCR for MRO on rectal swab and faecal culture negative for MRO after 16 weeks. This will be measured on rectal samples that will undergo PCR/culture for ESBL, VRE and CPO. The result from the test will be positive or negative

Time frame: 16 weeks

Number of participants with adverse events.

Number of participants with adverse events both severe and non-severe.

Time frame: 8 weeks, 16 weeks and 6 months.

Comparison of the frequency of invasive infections

Comparison of the frequency of invasive infections with the same MRO as the intestinal carriage between the FMT and the placebo group.

Time frame: 6 months

Comparison of mortality rates, frequency of hospitalization and isolation between the FMT and the placebo group.

Time frame: 6 months

Comparison of changes in the diversity of the intestinal microbiome between the FMT group and the placebo group.

Time frame: 8 weeks and 16 weeks