Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Another known gastrointestinal infection apart from C. difficile infection

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%

Trial population

Patients with recurrent Clostridioides difficile infection, treated with FMT

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • FMT from healthy donors

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Qualitative and quantitative characteristics of recipients' microbiome 30 days after FMT.

The investigators will evaluate the characteristics of recipients' microbiome, assessed by metagenomics analysis, 30 days after FMT compared with baseline.

Time frame
1 months

Secondary outcomes

1

Qualitative and quantitative characteristics of recipients' microbiome 7,15,90 days after FMT.

The investigators will evaluate the characteristics of recipients' microbiome, assessed by metagenomics analysis, 7,15,90 days after FMT compared with baseline.

Time frame
3 months
2

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

The number of participants with treatment-related adverse events (assessed by CTCAE v4.0) will be recorded throughout the study period.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.