Superdonor FMT in Patients With Ulcerative Colitis
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 indicatio
| Condition(s) | Active Ulcerative Colitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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 i |
| Who can participate | Inclusion Criteria: * Age between 18 and 75 years old * Mild to Moderate Ulcerative Colitis (total Mayo score 3 -10 + endoscopic subscore ≥ 1) in stable maintenance therapies (\> 4 weeks with Aminosalicylates, \> 6 weeks with immunosuppressant or biologics agents); * Recent diagnosis (\< 12 months) of Ulcerative Colitis; * Ability to provide written informed consent * Ability to be compliant with the scheduled procedures Exclusion Criteria: * Age \< 18 years old * Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, Crohn disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) * Previous colorectal surgery or cutaneous stoma * Current or recent (\< 2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antim |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Locations | Rome, Lazio, Italy |
| Start date | 2023-02-13 |
| NCT ID | NCT05739864 |
| Official listing | https://clinicaltrials.gov/study/NCT05739864 |