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A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (microbiota suspension) for the Prevention of Recurrent Clostridium difficile Infection

Primary Objective

Primary Objective: To confirm the efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI through 8 weeks. Secondary Objective: To evaluate the sustained clinical response rate of RBX2660 as compared to Placebo after blinded treatment.

Study category: Infectious Diseases

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Details
Age

Adult

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Scope

National

Location

University of Colorado Hospital

Principal Investigator
Shelby Sullivan,  MD

Shelby Sullivan, MD

Study ID

Protocol Number: 18-1344

More information available at ClinicalTrials.gov: NCT03244644

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