Status:
NOT_YET_RECRUITING
Evaluation of Gut Microbiota and Its Associated Resistome in FMT Donors and Recipients Due to Recurrent Clostridiodes Difficile Infection
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
CDI
Eligibility:
All Genders
18+ years
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 va...
Detailed Description
Background Negli ultimi anni è diventata evidente l'importanza del microbioma intestinale nel mantenimento dell'omeostasi dell'individuo oltre che essere associato ad alcuni stati di malattia. L'ospi...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
September 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06533800
Start Date
September 15 2024
End Date
August 15 2026
Last Update
August 1 2024
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