NCT05330182

LMN-201 for Prevention of C. Difficile Infection Recurrence

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 375 (estimated)
• Sponsor: Lumen Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridioides Difficile Infection

Interventions

Type	Name	Description
DRUG	LMN-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
DRUG	Placebo	Doses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules.

Timeline

• Start date: 2024-08-29
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2022-04-15
• Last updated: 2026-02-10

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study