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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called fecal microbiota transplantation (FMT) in patients who have both recurrent Clostridium difficile infection (CDI) and ulcerative colitis (UC). CDI is a common cause of severe diarrhea, especially in hospitalized patients, and it can be more frequent in people with inflammatory bowel diseases like UC. The trial aims to compare two approaches: a single infusion of FMT versus multiple infusions (a sequential approach) to see which one works better in eliminating recurrent CDI in patients with UC.

To participate in this trial, individuals must be at least 18 years old, have active UC, and be experiencing a recurring CDI infection. Participants will receive FMT from a healthy donor, and the study will help determine how effective each method of delivery is in treating their CDI. If you or someone you know is interested in this trial, it’s important to discuss it with a healthcare provider for more information and to see if they meet the eligibility criteria.

Gender

ALL

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.