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Superdonor FMT in Patients With Ulcerative Colitis

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllFondazione Policlinico Universitario Agostino Gem…
NCT05739864 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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. antimicrobials, probiotics, proton pump inhibitors or metformin) * Decompensated heart failure or heart disease with ejection fraction lower than 30% * Severe respiratory insufficiency * Psychiatric disorders * Pregnancy or breastfeeding * Unable to give informed consent
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What it tests

  • FMT
  • Placebo FMT
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Where

1 site
Gianluca Ianiro
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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