Fecal microbiota transplantation for recurrent C. difficile infection in ulcerative colitis patients

Fecal Microbiota Transplantation in Patients With Recurrent Clostridioides Cifficile Infection and Ulcerative Colitis: Single Infusion Versus Sequential Approach

This study is testing whether a single infusion of fecal microbiota transplantation can help people with ulcerative colitis who keep getting C. difficile infections feel better compared to a step-by-step approach.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Locations: 1 site (Rome)
• Trial ID: NCT06071312 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of fecal microbiota transplantation (FMT) in patients suffering from recurrent Clostridioides difficile infection (CDI) and ulcerative colitis (UC). It compares a single infusion of FMT to a sequential approach to determine which method is more effective in treating both the infection and the underlying UC. The study aims to address the higher prevalence and severity of CDI in patients with IBD, particularly those with UC, and seeks to improve their overall health outcomes. Participants will be monitored for improvements in their condition and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with active ulcerative colitis and a history of recurrent CDI.

Not a fit: Patients with other gastrointestinal infections, severe comorbidities, or those who have undergone certain previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of CDI and improve the management of ulcerative colitis in affected patients.

How similar studies have performed: Previous studies have shown promising results for FMT in treating recurrent CDI, but this specific approach in patients with ulcerative colitis is relatively novel.

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.

Where this trial is running

Rome

• Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS — Rome, Italy (Recruiting)

Study contacts

• Principal investigator: Gianluca Ianiro, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Gianluca Ianiro, MD

Conditions Clostridium Difficile; Ulcerative Colitis; Clostridium difficile; Fecal microbiota transplantation