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FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae

RecruitingPhase 1, Phase 2Ages 18 Years - 90 YearsAllFondazione Policlinico Universitario Agostino Gem…
NCT04759001 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes. Healthy gut microbiota is known to prevent the colonization of the gastrointestinal tract by pathogens, the so-called mechanism of colonization resistance, but this protective mechanism can be altered by therapies that impair gut microbiota, including antibiotics or chemotherapeutics, with consequent colonisation of gut pathogens, including multi-drug resistant bacteria (MDRB). MDRB carriers represent an epidemiological threat to other hospitalized patients and to the whole community, but are also at risk of developing clinical consequences of this colonization, including bloodstream infections from these pathogens. Fecal microbiota transplantation (FMT) has shown high efficacy in the eradication of recurrent C. di

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📋 Eligibility rules (as published)
Inclusion criteria * 18 years old or older * Current evidence of gut colonisation (diagnosed with rectal swab) by CRE * Ability to give their consent to be included in the study. Exclusion criteria * Another known gastrointestinal infection apart from C. difficile infection * Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) * Previous colorectal surgery or cutaneous stoma * Food allergies * Current or recent (\<2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin) * Decompensated heart failure or heart disease with ejection fraction lower than 30% * Severe respiratory insufficiency * Psychiatric disorders * Pregnancy * Unable to give informed consent
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What it tests

  • Donor FMT
  • Placebo FMT
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Where

1 site
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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