LMN-201 for Prevention of C. Difficile Infection Recurrence

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

375

Participants

Timeline

Start Date

August 29, 2024

Primary Completion Date

December 1, 2025

Study Completion Date

April 1, 2026

Conditions
Clostridioides Difficile Infection
Interventions
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.

Trial Locations (17)

10021

RECRUITING

Weill Cornell Medicine, New York

22003

RECRUITING

Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC, Annandale

27030

RECRUITING

IMA Clinical Research, Mount Airy

30033

RECRUITING

Metro Infectious Disease Consultants - Atlanta, Decatur

34102

RECRUITING

GI PROS Research, Naples

40503

RECRUITING

Baptist Health Research, Lexington

44060

RECRUITING

The Clinical Trials Network, LLC, Willoughby

55455

RECRUITING

University of Minnesota, Minneapolis

59701

RECRUITING

Mercury Street Medical, Butte

60453

RECRUITING

DM Clinical Research, Oak Lawn

60527

RECRUITING

Metro Infectious Disease Consultants, LLC, Burr Ridge

68114

RECRUITING

Quality Clinical Research, Inc, Omaha

77030

RECRUITING

MD Anderson Cancer Center, Houston

83404

RECRUITING

Snake River Research, Idaho Falls

90027

RECRUITING

Kaiser Permanente, Escondido

06610

RECRUITING

Bridgeport Hospital, Bridgeport

06518

RECRUITING

Gastroenterology Center of Connecticut, Hamden

Sponsors
All Listed Sponsors
collaborator

Congressionally Directed Medical Research Programs

FED

lead

Lumen Bioscience, Inc.

INDUSTRY