Actively Recruiting
Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-03-19
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrent Clostridioides difficile infection
- Age between 18 and 90 years old
- Ability to provide written informed consent
- Ability to comply with scheduled procedures
You will not qualify if you...
- Presence of other gastrointestinal infections apart from Clostridioides difficile infection
- Active gastrointestinal disorders such as infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, or biliary salt diarrhea
- Previous colorectal surgery or presence of a cutaneous stoma
- Current or recent (within 6 weeks) use of drugs that could alter gut microbiota, such as antimicrobials or probiotics
- Decompensated heart failure or heart disease with ejection fraction below 30%
- Severe respiratory insufficiency
- Psychiatric disorders
- Pregnancy or breastfeeding
- Inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Actively Recruiting
Research Team
G
Gianluca Ianiro, MD, PhD
CONTACT
S
Serena Porcari, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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