Status:
RECRUITING
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Clostridium Difficile
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 24 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06071312
Start Date
September 23 2023
End Date
September 24 2025
Last Update
March 11 2025
Active Locations (1)
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1
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS
Rome, Italy, 00168