Clinical Research Studies

This is a prospective observational cohort study designed to collect data on patients who received REBYOTA for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA is at the treating physician’s discretion and independent from the decision to enroll the patient in the study. Adult patients who receive a prescription for REBYOTA to prevent rCDI are eligible to enroll according to the inclusion and exclusion criteria described below. Patients must enroll in the study between prescription and administration. This allows time for patients to enroll while still conducting the baseline measurement of patient-reported outcomes (CDI-DaySyms™) prior to administration. REBYOTA For each patient, the current or presenting rCDI episode will be defined as the CDI episode just prior to receiving REBYOTA. If a patient receives REBYOTA more than once, the first dose will be used to define the presenting rCDI and to assess REBYOTA effectiveness. Baseline period will be defined as the time period between the date REBYOTA is prescribed and the date REBYOTA is administered. Data will be collected from patients’ medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, AEs, and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA administration.