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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-24

Study Completion Date

2028-11-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Multidrug Resistant Organisms Faecal Microbiota Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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FMT (faecal microbiota transplantation)

25-30 capsules of faecal material.

Group Type EXPERIMENTAL

Faecal microbiota transplantation

Intervention Type OTHER

25-30 capsules of faecal material

Placebo

25-30 placebo capsules.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

25-30 placebo capsules

Interventions

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Faecal microbiota transplantation

25-30 capsules of faecal material

Intervention Type OTHER

Placebo

25-30 placebo capsules

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No