Clostridium difficile infection (CDI) is a disease associated with the wide-spread use of antibiotics and causes 450,000 infections and almost 30,000 deaths in the United States annually. Recurrence is a major problem, with approximately 1/3rd of patients relapsing after antibiotic treatment for CDI. Fecal Microbiota Transplantation (FMT) has emerged as a novel therapy for recurrent CDI, but the majority of the literature to date is made up of uncontrolled case series, so FMT’s true efficacy compared with standard antibiotic regimens remains unknown. Only a few randomized control trials (RCTs) have been published, and these have studied small numbers of patients and exhibited marked methodological heterogeneity. As such, there is uncertainty about the appropriate indications for FMT with respect to recurrent CDI, as well as the best methodology for the procedure, which has been carried our using various fecal preparations and modes of delivery. In particular, questions remain about if FMT should be recommended for patients with a first CDI recurrence, and if minimally invasive methods of performing FMT such as administration of enteric coated capsules are more efficacious than standard antibiotic treatments. We propose a double blind, placebo controlled, RCT that will be run as two parallel RCTs, where Trial 1 will enroll patients experiencing a first CDI recurrence, and Trial 2 will enroll patients experiencing a second or later CDI recurrence. The treatment arms in each trial will receive FMT in the form of orally administered frozen capsules, while the control arms will receive standard antibiotic treatments based on the number of recurrences they have experienced. If shown to be efficacious in a large RCT, oral capsulized FMT alone as treatment for recurrent CDI has the potential to increase access to FMT, decrease unnecessary antibiotic use, and substantially reduce morbidity and mortality attributable to CDI.
| Identifer | oai:union.ndltd.org:bu.edu/oai:open.bu.edu:2144/32969 |
| Date | 24 October 2018 |
| Creators | Hamilton, Mariah |
| Contributors | Hibberd, Patricia, Weinstein, John |
| Source Sets | Boston University |
| Language | en_US |
| Detected Language | English |
| Type | Thesis/Dissertation |
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