Evaluation of Gut Microbiota and Its Associated Resistome in FMT Donors and Recipients Due to Recurrent Clostridiodes Difficile Infection

NCT06533800 | Not Yet Recruiting

• 1 other identifier: 6422
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Caratterizzazione della composizione microbica intestinale nei donatori di FMT e nei pazienti affetti da rCDI al tempo basale e a seguito del trapianto di microbiota fecale. Negli stessi time point valutare il resistoma associato alla comunità microbica rilevata.

Conditions

CDI

Outcome Measures

Primary Outcomes (1)

• Assessment of gut microbiota e associated resitome

  Characterization of intestinal microbial composition in FMT donors and patients with rCDI at baseline time and following fecal microbiota transplantation. In the same time points evaluate the resistance associated with the microbial community detected.

  24 months

Eligibility Criteria

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

Study Population

CDI patients - FMT donors

You may qualify if:

• patients with rCDI (\> 18 years) to whom faecal microbiota transplantation is indicated, without other pathologies or prolonged hospitalization periods
• donors: healthy volunteers aged between 18 and 50 years
• Patients capable of expressing consent

You may not qualify if:

• antibiotic therapies in the last 30 days
• treatments with prebiotics - probiotics - postbiotics in the last 60 days
• colonization by MDR or XDR pathogens
• presence of pre-existing or ongoing intestinal pathologies (Inflammatory Intestinal Diseases, chronic hepatitis, celiac disease, neoplasms, previous large intestinal resections)
• ongoing diarrhea of any origin (defined as more than 6 watery stools per day and/or faecal volume greater than 250 ml in 24 hours)
• severe septic state in progress
• for donors: drug addiction, promiscuous sexual behaviour, use of drugs that can be excreted in the faeces with potential risk for recipients

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Design

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

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 1, 2024
• Study Start: September 15, 2024
• Primary Completion: August 15, 2025
• Study Completion (Estimated): August 15, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share