A Randomized Placebo-Controlled Double-Blind Phase 1 Study of ART24 in Subjects Recently Cured of a Clostridioides difficile Infection (CDI)

Brief description of study

The purpose of this study is to evaluate the safety and tolerability of ART24 after 28 days of daily administration for subjects who have already taken antibiotics for C. difficile infections (CDI). The goal of daily oral administrations is to kill germinated and growing, persistent or newly acquired, C. difficile in the gut, and thus decrease the risk of CDI recurrence. ART24 is an investigational drug composed of freeze-dried gut-friendly bacteria called Bacillus velezensis which acts against the bacteria C. difficile. It will be taken orally in the form of a capsule each day in the morning on an empty stomach, at least 1 hour before a meal. Although the bacteria contained in the study drug is found in the environment and human body, this is the first time the investigational drug will be tested in humans. It has not been approved by the US Food and Drug administration as a treatment for CDI.


Clinical Study Identifier: s21-01006
ClinicalTrials.gov Identifier: NCT04891965
Principal Investigator: Jordan E Axelrad.


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