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Study identifier: NCT05739864 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Superdonor FMT in Patients With Ulcerative Colitis

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

PhasePhase 1/Phase 2
Planned participants42
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

In the last decades fecal microbiota transplantation (FMT) has been established as a highly effective option in the treatment of recurrent Clostridioides difficile infection (rCDI), with a success rate of nearly 90%. For this reason, it is recommended by international guidelines as a treatment option for this indication in clinical practice. Recently, a considerable body of evidences, suggest FMT as an effective and safe treatment in patients affected by Ulcerative Colitis (UC). In a recent meta-analysis of 324 subjects with UC, 30.4% of patients achieved both clinical and endoscopic remission after FMT compared to placebo (9.8%, P\<0.00001). However, among the various published trials there is a fair variability in terms of methods and results, which are not comparable to those obtained in the rCDI. Nowadays, one of the most critical factors involved in the effectiveness of FMT in UC patients, is the choice of the donor. In addition, several studies have shown that some donors are associated with a higher clinical response rate than others. This hypothesis has been demonstrated in patients affected by irritable bowel syndrome, in which the use of a super-donor (a healthy person who has the predictive clinical and lifestyle characteristics of a healthy microbiota, and with a microbial profile associated with favorable clinical conditions) resulted in significantly higher clinical efficacy rates than placebo, similar to those obtained in rCDI (89%). Currently, studies that…

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)

Gianluca IaniroRome, Lazio, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT05739864