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Study identifier: NCT06071312 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Clostridium Difficile · Ulcerative Colitis  ·  Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PhasePhase 1/Phase 2
Planned participants64
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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 population, with a cumulative lifetime risk of 10 %. The higher risk to the development of CDI in patient with IBD is directly related to the microbiome alterations that are associated with this chronic disoder. Moreover, the use of antibiotics to cure CDI further worsens the gut microbiota, triggering potentially a self-maintaining cycle and predisposes such patients to a higher risk of recurrence. In these patients, CD superinfection is associated, with an increased rate of hospitalization, length of stay, the need to modify the treatment to the underlying disease, the increase rate of colectomy, there higher mortality rate, with a net increase of health costs. Nowadays, as emerged by several studies FMT has been established as a valid treatment option against recurrent CDI (rCDI), and it is recommended by international guidelines. Unfortunately, most FMT studies for rCDI have excluded patients with IBD. Recent evidence suggests that FMT is effective in patients with ulcerative colitis (UC) and concomitant rCDI, both in the treatment of the infection and in the improve of disease activ…

This description comes directly from the study's public registry record.

Talk to the study team

Gianluca Ianiro, MD  ·  +39 0630157338  ·  gianluca.ianiro@unicatt.it

Serena Porcari, MD  ·  +39 0630157338  ·  porcariserena89@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCSRome, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06071312