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RECRUITING
NCT05739825

Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

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.

Official title: Assessment Of Changes In Gut Microbiota Of Patients With Recurrent Clostridioides Difficile Infection After Fecal Microbiota Transplantation: Prospective Study

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2023-02-13

Completion Date

2027-02-14

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

OTHER

FMT from healthy donors

This intervention is represented by the administration, in the recipients' gut, of healthy donor microbiota through FMT

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy