A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence
Lumen Bioscience, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 days before first dose of LMN-201/placebo), and no other likely explanation for diarrhea. NOTE: Diarrhea is not required to be present on the day of enrollment. 3. Provision of signed and dated informed consent form. 4. Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic…
Interventions
- DrugLMN-201
LMN-201 consists of orally delivered whole, dried, non-viable biomass of spirulina (Arthrospira platensis) grown from 4 separate strains, each of which has been engineered to express one of the following therapeutic proteins: * 3 toxin-binding proteins that bind and inhibit C. difficile toxin B (TcdB), an essential virulence factor for C. difficile * 1 lysozyme-like enzyme that selectively degrades the cell wall of C. difficile and causes rapid destruction of the organism
- DrugPlacebo
Doses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules.
Locations (16)
- Kaiser PermanenteEscondido, California
- Bridgeport HospitalBridgeport, Connecticut
- Gastroenterology Center of ConnecticutHamden, Connecticut
- GI PROS ResearchNaples, Florida
- Metro Infectious Disease Consultants - AtlantaDecatur, Georgia
- Snake River ResearchIdaho Falls, Idaho