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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 (PUNCH)
Primary Objective:
To evaluate the safety and tolerability of RBX2660 in subjects with recurrent CDI.
Secondary Objectives:
1. To evaluate the efficacy of RBX2660 in preventing recurrent episodes of CDI through 8 weeks after treatment.
2. To evaluate the sustained clinical response rate of RBX2660 after treatment.
Primary Objective:
To evaluate the safety and tolerability of RBX2660 in subjects with recurrent CDI.
Secondary Objectives:
1. To evaluate the efficacy of RBX2660 in preventing recurrent episodes of CDI through 8 weeks after treatment.
2. To evaluate the sustained clinical response rate of RBX2660 after treatment.
Recruitment Status
Past Studies