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

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllFondazione Policlinico Universitario Agostino Gem…
NCT06071312 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 o

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📋 Eligibility rules (as published)
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 Exclusion Criteria: * Age \< 18 years; * Other gastrointestinal infections, excluding C. difficile; * Known gastrointestinal diseases, other than UC, in active stage (e.g., infectious gastroenteritis, celiac disease, irritable bowel syndrome, chronic pancreatitis, bile acid diarrhea, etc.); * Previous colon surgery or skin ostomy packing; * Food allergies; * Current or recent (\<2 weeks) therapy with drugs that may alter the microbiota (e.g., systemic antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin), except antibiotics against C. difficile; * Heart failure or heart disease with FE ≤ 30 %; * Severe respiratory failure; * Psychiatric disorders; * Pregnancy and lactation; * Inability to provide informed consent.
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What it tests

  • single FMT
  • sequential FMT
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Where

1 site
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
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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