Assessment Of Changes In Gut Microbiota Of Patients With Recurrent Clostridioides Difficile Infection After Fecal Microbiota Transplantation: Prospective Study
Sponsor study identifier
observational
20
1 country
1
Study Start
February 13, 2023
Actual (reported)Primary Completion
February 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2023
Actual (reported)February 13, 2023
Actual (reported)February 22, 2023
Actual (reported)February 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
1 months
Qualitative and quantitative characteristics of recipients' microbiome 7,15,90 days after FMT.
3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
3 months
This intervention is represented by the administration, in the recipients' gut, of healthy donor microbiota through FMT
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with recurrent Clostridioides difficile infection, treated with FMT
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Miller BA, Chen LF, Sexton DJ, Anderson DJ. Comparison of the burdens of hospital-onset, healthcare facility-associated Clostridium difficile Infection and of healthcare-associated infection due to methicillin-resistant Staphylococcus aureus in community hospitals. Infect Control Hosp Epidemiol. 2011 Apr;32(4):387-90. doi: 10.1086/659156.
Dubberke ER, Olsen MA. Burden of Clostridium difficile on the healthcare system. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S88-92. doi: 10.1093/cid/cis335.
human feces. The human DNA will be discarded and not analysed at the time of the analysis
Gianluca Ianiro
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First Submitted
February 13, 2023
First Posted
February 22, 2023
Study Start
February 13, 2023
Actual (reported)Primary Completion
February 14, 2027
EstimatedBezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection
Contact the study team to confirm eligibility.
Falcone M, Russo A, Iraci F, Carfagna P, Goldoni P, Vullo V, Venditti M. Risk Factors and Outcomes for Bloodstream Infections Secondary to Clostridium difficile Infection. Antimicrob Agents Chemother. 2015 Oct 19;60(1):252-7. doi: 10.1128/AAC.01927-15. Print 2016 Jan.
Quraishi MN, Widlak M, Bhala N, Moore D, Price M, Sharma N, Iqbal TH. Systematic review with meta-analysis: the efficacy of faecal microbiota transplantation for the treatment of recurrent and refractory Clostridium difficile infection. Aliment Pharmacol Ther. 2017 Sep;46(5):479-493. doi: 10.1111/apt.14201. Epub 2017 Jul 14.
Cammarota G, Masucci L, Ianiro G, Bibbo S, Dinoi G, Costamagna G, Sanguinetti M, Gasbarrini A. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015 May;41(9):835-43. doi: 10.1111/apt.13144. Epub 2015 Mar 1.
Surawicz CM, Brandt LJ, Binion DG, Ananthakrishnan AN, Curry SR, Gilligan PH, McFarland LV, Mellow M, Zuckerbraun BS. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013 Apr;108(4):478-98; quiz 499. doi: 10.1038/ajg.2013.4. Epub 2013 Feb 26.
Debast SB, Bauer MP, Kuijper EJ; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014 Mar;20 Suppl 2:1-26. doi: 10.1111/1469-0691.12418.
Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 19, 2026
Record last verified: 2026-03
Individual participant data will be available to other researchers
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