Fecal Microbiota Transplant for Primary CDI

Population: Patients \>= 18 years hospitalized at Boston Medical Center (BMC) with a first documented episode of CDI. Intervention: 30 FMT capsules administered orally under direct observation within 7 days of completion of 10-14 day treatment of oral vancomycin for CDI. Objectives: 1. To characterize the microbial diversity in stool samples from subjects with a primary episode of CDI before and after oral vancomycin and determine the impact of FMT after completion of oral vancomycin course. 2. To characterize the feasibility and tolerability of FMT after completion of a course of oral vancomycin therapy for primary CDI, and to describe 30-day hospital readmission and gastrointestinal symptomatology and/or CDI recurrence during 60-day follow-up. Design/Methodology: 15 subjects will be enrolled who are hospitalized at BMC for a primary episode of CDI. A discard aliquot from baseline stool samples obtained clinically for diagnosis will be frozen. Subjects will receive the standard of care treatment (oral vancomycin for 10-14 days) and within 7 days following completion will receive oral FMT during a 2 hour visit in the Infectious Disease (ID) Clinical Trials Unit. An additional 5 subjects will be enrolled as controls. Stool samples will be collected at time of CDI diagnosis and again 3 weeks after FMT for intervention group and 4 weeks after completion of oral vancomycin treatment for control subjects. The post-treatment samples will be obtained by the patient using special stool sample collection kits known as RNAlater kits (ribonucleic acid stabilization). These contain a liquid nontoxic tissue storage reagent known as RNAlater and helps preserve the stool sample. The subjects will mail this stool sample to the BMC Clinical Trials Unit (CTU) where it will aliquoted, centrifuged and frozen. Samples will be processed at a collaborating lab at Tufts to characterize the fecal microbiome pre- and post oral FMT. Study personnel will contact participants via telephone 60 days after FMT dosing to administer a follow-up survey (including questions on residual symptoms. CDI recurrence, re-hospitalization, adverse events and FMT acceptability). Total Study Duration: Anticipated time: 12 months Subject Participation Duration: The researchers anticipate a period of 1-2 hours while an inpatient for the screening and consent process, 2 hours for the CTU visit for FMT and 20-30 minutes responding to a follow up telephone survey. Total time in the study from enrollment to completion of follow-up will be approximately 3 months and will include 10-14 days of CDI treatment with oral vancomycin (per standard of care treatment), the FMT administration and a 60 day follow up.