Fecal Microbiota Transplantation by Colonoscopy for Recurrent C. Difficile Infection: an Open-label Randomized Clinical Trial

In the recent past, a deep change in the epidemiology of C. difficile infection has occurred, with a rise in its frequency, severity, and mortality. Both the refractoriness of the infection to standard therapy and its probability of recurrence have also increased, representing a main clinical issue. Fecal microbiota transplantation (FMT) refers to the introduction of a liquid filtrate of stools from a healthy donor into the gastrointestinal tract of a patient for the treatment of specific diseases. FMT has shown outstanding results in the treatment of recurrent C. difficile infection. It can be performed through various routes: nasogastric or nasojejunal tube, upper endoscopy, retention enema, colonoscopy. In a recent systematic review of studies using FMT for the treatment of recurrent C. difficile infection, Cammarota et al. observed that lower gastrointestinal route (colonoscopy, enema) led to the achievement of higher eradication rates than upper delivery (gastroscopy, naso-gastric or naso-jejunal tube) (81-86% vs 84-93%, respectively). In a randomized clinical trial, Van Nood et al. showed the efficacy of FMT by nasojejunal tube in recurrent C. difficile infection. Up to now, data on FMT by lower route come out only by case series and case reports.

The investigators' aim is to compare the efficacy of colonoscopic FMT and standard antibiotic therapy for the treatment of C. difficile infection in an open-label randomized clinical trial The investigators' trial should confirm the clinical results obtained by Van Nood et al. by using a colonoscopy approach.

The investigators' study is an open-label randomized controlled trial, enrolling patients with recurrent C. difficile infection, who are candidates for further antibiotic treatment in accordance with guidelines. Recurrent C. difficile infection is meant as the reappearance of clinical symptoms and positivity of C. difficile toxin test within 8 weeks after the end of the previous therapy. Patients' stool will be screened for detection of parasites and enteric bacterial pathogens to exclude other infective pathogens. Patients with severe clinical features (sepsis, severe dehydration, major co-morbidities), former colectomy, high-risk of endoscopic complications, inflammatory bowel diseases (IBD), irritable bowel syndrome (IBS), viral hepatitis, AIDS or syphilis will be excluded.

Patients will be instructed and invited to signal recurrent symptoms and diarrhea after treatment. Monthly clinical and lab checks will be performed for a period of six months after the treatment.

Treatment procedures: