Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation

NCT05739825 | Recruiting

• 1 other identifier: 3555
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clostridioides Difficile Infection Recurrence

Keywords

Clostridioides difficile infection; Fecal Microbiota Trasplantation; Engraftment

Outcome Measures

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.

  1 months

Secondary Outcomes (2)

• 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

Interventions

FMT from healthy donors OTHER

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent Clostridioides difficile infection, treated with FMT

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 21460491 BACKGROUND

• 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.

  PMID: 22752870 BACKGROUND

• 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.

  PMID: 26482315 BACKGROUND

• 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.

  PMID: 28707337 BACKGROUND

• 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.

  PMID: 25728808 BACKGROUND

• 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.

  PMID: 23439232 BACKGROUND

• 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.

  PMID: 24118601 BACKGROUND

• 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.

  PMID: 28087657 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

human feces. The human DNA will be discarded and not analysed at the time of the analysis

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Gianluca Ianiro

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Ianiro, MD, PhD

CONTACT

+390630157338; gianluca.ianiro@unicatt.it

Serena Porcari, MD

CONTACT

+390630157338; porcariserena89@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: February 13, 2023
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will be available after the completion of the study, for 5 years
• Access Criteria: Data will be given upon request to the PI

Locations

IT (1)