FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
Clostridium Difficile, Ulcerative Colitis
About this trial
This is an interventional treatment trial for Clostridium Difficile focused on measuring Ulcerative Colitis, Clostridium difficile, Fecal microbiota transplantation
Eligibility Criteria
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.
Sites / Locations
- Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
. Single FMT
Sequential FMT
Patients enrolled in this arm will receive a single infusion of donor FMT
Patients enrolled in this arm will receive sequential infusions of donor FMT