Overview

Fecal Microbiota Transplantation by Colonoscopy for Recurrent C. Difficile Infection

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
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 a randomized clinical trial
Phase:
Phase 2
Details
Lead Sponsor:
Catholic University of the Sacred Heart
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Vancomycin