LMN-201 for Prevention of C. Difficile Infection Recurrence

Part of paid clinical trials in Escondido, California.

Sponsor
Lumen Bioscience, Inc.
Study ID
NCT05330182
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Clostridioides Difficile Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LMN-201 — DRUG
    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
  • Placebo — DRUG
    Doses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules.

Study Details

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.

Key Dates

Start date
Aug 29, 2024
Status verified
Feb 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Sentinel Cohort
  • Active Comparator: LMN-201
  • Placebo Comparator: Placebo

Primary Outcome Measure

Proportion of participants who achieve global cure [ Time Frame: Up to 16 weeks after initiation of therapy ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Kaiser PermanenteEscondidoCalifornia90027
Primary Coordinator
626-372-7499
Bridgeport HospitalBridgeportConnecticut06610
Primary Coordinator
203-384-4700
Gastroenterology Center of ConnecticutHamdenConnecticut06518
Primary Coordinator
203-281-5112
GI PROS ResearchNaplesFlorida34102
Primary Coordinator
239-649-1336
Metro Infectious Disease Consultants - AtlantaDecaturGeorgia30033
Primary Coordinator
404-297-5008
Snake River ResearchIdaho FallsIdaho83404
Primary Coordinator
208-535-8406
Metro Infectious Disease Consultants, LLCBurr RidgeIllinois60527
Primary Coordinator
630-655-8441
DM Clinical ResearchOak LawnIllinois60453
Primary Coordinator
(708) 253-5810
Baptist Health ResearchLexingtonKentucky40503
Primary Coordinator
859-639-3720
University of MinnesotaMinneapolisMinnesota55455
Primary Coordinator
612-625-2998
Mercury Street MedicalButteMontana59701
Primary Coordinator
406-723-1387
Quality Clinical Research, IncOmahaNebraska68114
Primary Coordinator
(402) 934-0044
Weill Cornell MedicineNew YorkNew York10021
Primary Coordinator
646-962-9358
646-962-2085
IMA Clinical ResearchMount AiryNorth Carolina27030
Primary Coordinator
336-415-5507
MD Anderson Cancer CenterHoustonTexas77030
Primary Coordinator
3467251272
Clinical Alliance for Infectious Diseases - Infectious Diseases, LLCAnnandaleVirginia22003
Primary Coordinator
7035604821

Find similar trials in Escondido, CA

By research site
Kaiser Permanente· Escondido, CABridgeport Hospital· Bridgeport, CTGastroenterology Center of Connecticut· Hamden, CTGI PROS Research· Naples, FLMetro Infectious Disease Consultants - Atlanta· Decatur, GASnake River Research· Idaho Falls, ID

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