FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach

Recruiting Phase 1 Phase 2 Interventional Study
Clostridium Difficile Ulcerative Colitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Other
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About This Trial
Clostridioides difficile infection (CDI) is the most frequent cause of infectious diarrhea in hospitalized patients and is responsible for 20-30 % of antibiotic-associated diarrhea cases. Inflammatory bowel diseases (IBD) are associated with an higher prevalence, recurrence and severity of CDI. The prevalence of recurrent CDI in patients with IBD is 2.5 to 8 times higher than in the general popula…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥18 years; * Active UC (partial Mayo score ≥2); * Relapsing infection of C. difficile; * Ability to express consent for inclusion in the study. * Indication, in the clinical practice setting, for fecal microbiota transplantation from a healthy donor for recurrent CDI Excl…
Contacts

Gianluca Ianiro, MD

+39 0630157338

gianluca.ianiro@unicatt.it

CONTACT

Serena Porcari, MD

+39 0630157338

porcariserena89@gmail.com

CONTACT