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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: gianluca.ianiro@unicatt.it
• Phone: +39 0630157338

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.