Abstract
Recurrent Clostridiodes difficile infections (rCDIs) are a burdensome problem. Patients with a history of CDI that are prescribed antibiotics are at a high risk for recurrence. Fecal microbiota transplantation (FMT) has been shown to be an effective treatment for rCDI, though there is little information on the impact of FMT with antibiotics on the gut microbiome. We are conducting a clinical trial of FMT to prevent rCDI in patients with a history of CDI currently taking antibiotics. Our primary objective is to determine the effect of FMT on the gut microbiome during antibiotic exposure. Our secondary aim is to assess safety and feasibility of using FMT as a prophylaxis for CDI. We plan to enroll 30 patients into a phase II randomized, double-blind, placebo-controlled trial with three arms: (1) 5 FMT capsules per day during antibiotic treatment and for 7 days post antibiotic cessation, (2) a one-time dose of 30 FMT capsules 48–72 h post cessation of antibiotic treatment, or (3) 5 placebo capsules per day during antibiotic treatment and for 7 days post antibiotic treatment. Patients provide stool samples throughout the duration of the study and are cultured C. difficile. Sequencing of the V4 region of the 16S rRNA gene will be carried out to assess the gut microbiota. Results of this study will provide information on the impact of FMT on the gut microbiome as well as the necessary data to examine whether or not prophylactic FMT should be explored further as a way to prevent CDI recurrence.
Highlights
Clostridioides difficile infection (CDI) is considered an urgent public health threat by the Centers for Disease Control and Prevention [1] and was the number one pathogen causing healthcare-associated infections in 2015 [2]
Recurrent CDI is thought to be due to the inability of the intestinal microbiota to re-establish after antibiotic treatment causing a state of dysbiosis
We will evaluate the effect of two different methods of Fecal microbiota transplantation (FMT) administration – one administered at a single, high dose following cessation of antibiotic treatment or one adminis tered at a low dose daily during antibiotic treatment and for one week following antibiotic cessation – compared to placebo, and their impact on the gastrointestinal microbiome
Summary
Clostridioides difficile (formally Clostridium difficile) infection (CDI) is considered an urgent public health threat by the Centers for Disease Control and Prevention [1] and was the number one pathogen causing healthcare-associated infections in 2015 [2]. Recurrence rates for CDIs have been reported to occur in an average of 20% of primary cases due to increased treatment difficulty [3,4,5]. Recurrent CDI is thought to be due to the inability of the intestinal microbiota to re-establish after antibiotic treatment causing a state of dysbiosis. This dysbiosis leaves the patient susceptible to infection either by a new strain of C. difficile or re-infection with the original infecting strain [7]. New antibiotic exposure is one of the major risk factors for recurrent CDIs [6]. In patients with recurrent CDI, the gut microbiota are in a continuous state of dysbiosis allowing C. difficile to proliferate [8]. FMT has been shown to be a highly effective and inex pensive treatment for recurrent CDI with studies showing up to 89% of patients treated with FMT having resolution of their CDI after just one
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