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PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium Difficile Infection

Clinical Trial Details

This clinical trial is for men and women who are 18 years or older and have been diagnosed with recurrent Clostridium difficile infection (referred to as CDI) and were a participant in the CDI-001 study. This trial is being conducted to evaluate the potential side effects and effectiveness of taking a single dose (10 capsules) of the test/study drug CP101 versus after previous study administration with the study drug CP101 or placebo. 

An investigational drug is an experimental drug that is currently being tested and has not been approved by the Food and Drug Administration (FDA) for use.

Eligible participants will be given the study drug CP101 capsules given orally on Day 1. 

Participation will last about 24 weeks (6 months). Participants will be required to visit the clinic at least 4 times. Study participants will be compensated for their time. 

Key Eligibility: 

Men and women who are 18 years of age and older
Have been diagnosed with recurrent Clostridium difficile infection
Previously participated in the CDI-001 study
Detailed eligibility reviewed when you contact the study team
    

Study contact by location

Upper East Side - Manhattan

Contact(s)

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1806019363

ClinicalTrials.gov:

NCT03497806

Sponsor:

CP101-CD1-E02

Status

Open to Enrollment

Age Group

Adult

Sponsor