CompletedNot Applicable

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

Denmark83 participantsStarted 2023-03-24

Plain-language 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).

Who can participate

Age range

18 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with MRO clearance

Timeframe: 8 weeks

Trial details

NCT IDNCT05742074

SponsorHvidovre University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-11

View on ClinicalTrials.gov More Multidrug Resistant Organisms trials