Detail

Study ID: Rebiotix 2019-01 Punch CD3-OLS Open Label Study

Title:

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection.

Description:
Title: A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection Description: The purpose of this study is to evaluate the safety and tolerability of RBX2660 in subjects with recurrent CDI who have had prior recurrent CDI that was resolved with antibiotic treatment. 4 Key Inclusion/Exclusion Criteria including Age Range If Applicable: • Must be ≥ 18 years old • Must have medical record documentation of either recurrent Clostridium difficile Infection or has had at least two episodes of severe Clostridium difficile Infection resulting in hospitalization • Unable to participate if you’ve had fecal microbiota transplant (FMT) within the past 6 months • Unable to participate if you require systemic antibiotic therapy for a condition other than Clostridium difficile Infection
Location:
Fargo Region
Principal Investigator:
Avish Nagpal, MD
Disease:
Gastric, Gastrointestinal, Other
Stage:
Phase III
Status:
Active - Open to Accrual