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Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation

Recruitingn/aAges 18 Years - 90 YearsAllFondazione Policlinico Universitario Agostino Gem…
NCT05739825 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Clostridioides difficile infection (CDI) is the most common cause of nosocomial diarrhea, and the most common health care-associated infectious disease in the United States, accounting for 15% of overall infections, nearly 30.000 deaths per year an estimated economic expense of $5 billion/year. In the last decade, most of the burden related to CDI depends on recurrence CDI (rCDI) (3). rCDI is known to extend the hospitalization length, and to be associated with increased morbidity and mortality rates. Furthermore, rCDI is often, more than primary infection, associated with life-threatening complications, including pseudomembranous colitis, toxic megacolon, shock, perforation, bloodstream infection (BSI), sepsis, caused by intestinal bacteria or fungi with a mortality rate nearly 50%, and death. Fecal microbiota transplantation (FMT), defined as the infusion of feces from healthy donors

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📋 Eligibility rules (as published)
Inclusion Criteria: * Recurrent Clostridioides difficile infection * Age between 18 and 90 years old * Ability to provide written informed consent * Ability to be compliant with the scheduled procedures 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 * Current or recent (\< 6 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics) * Decompensated heart failure or heart disease with ejection fraction lower than 30% * Severe respiratory insufficiency * Psychiatric disorders * Pregnancy or breastfeeding * Unable to give informed consent
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What it tests

  • FMT from healthy donors
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Where

1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 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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