Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation

Recruiting now

Conditions studied: Clostridioides Difficile Infection Recurrence

In brief

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 to recipient with disorders associated to dysbiosis, is known to be a highly effective treatment option against CDI. FMT is also more effective than standard treatment with vancomycin and it is recommended by International Guidelines for treating multiple recurrence of CDI. Despite the increasing body of evidence about the clinical efficacy of FMT for the treatment of rCDI, mechanisms for this clinical efficacy are also unknown. Metagenomics analysis is known as a good option to examine gut microbiota and to estimate microbial diversity. The aim of this study is to evaluate changes in microbial composition in rCDI patients after FMT, using metagenomics analysis.

Key facts

Study ID: NCT05739825
Run by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
People needed: 20
Starts: 2023-02-13
Expected to finish: 2027-02-14
Last updated by the study team: 2026-03-19

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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