LMN-201 for Prevention of C. Difficile Infection Recurrence
Recruiting
Phase 2
Phase 3
Interventional Study
Clostridioides Difficile Infection
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 375 (estimated)
- Sponsor
- Lumen Bioscience, Inc. · Industry
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About This Trial
This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female, aged 18 or older.
2. Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5, 6, or 7); a positive stool C. difficile toxin B immunoassay (stool collected no more than 7…
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