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
2 other identifiers
interventional
375
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2024
Typical duration for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedStudy Start
First participant enrolled
August 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 10, 2026
February 1, 2026
2.8 years
April 8, 2022
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants who achieve global cure
Proportion of total participants with both successful initial CDI treatment and no CDI recurrence during the Prevention and Observation Phases (by treatment assignment).
Up to 16 weeks after initiation of therapy
Study Arms (3)
Sentinel Cohort
EXPERIMENTALLMN-201
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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
Doses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules.
Eligibility Criteria
You may qualify if:
- Male or female, aged 18 or older.
- 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.
- Provision of signed and dated informed consent form.
- Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7 or fewer days at time of initial study drug administration. SOC antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6)
- May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
- Ability to take oral medication and willingness to adhere to the study medication regimen.
- Stated willingness and ability to comply with all study procedures and availability for the duration of the study and investigator believes individual will complete the study.
- Access to a mobile smartphone.
- For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration.
- For males of reproductive potential: agreement to use condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration.
You may not qualify if:
- Fulminant C. difficile colitis.
- Admitted or expect to be admitted to an intensive care unit.
- Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.).
- Neutropenia (absolute neutrophil count of \< 1000 per microliter for any reason).
- Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the following:
- Bezlotoxumab (Zinplava, Merck \& Co.), or another antibody against C. difficile toxin(s)
- C. difficile vaccine
- SER-109 (Seres Therapeutics)
- CP101 (Finch Therapeutics)
- VE303 (Vedanta Therapeutics)
- Fecal microbiota transplant
- Current therapy with oral exchange resins
- Protracted exposure to mu-agonist opioids and/or anticholinergic medication prescribed for diarrheal symptoms (unable to stop mu-agonist opioid treatment unless on a stable dose as of onset of diarrhea and no increase in dose planned for the duration of the study.)
- Treatment with SOC antibiotic therapy is planned for longer than a 28-day period.
- Pregnancy, anticipated pregnancy, or breastfeeding.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Kaiser Permanente
Escondido, California, 90027, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Gastroenterology Center of Connecticut
Hamden, Connecticut, 06518, United States
GI PROS Research
Naples, Florida, 34102, United States
Metro Infectious Disease Consultants - Atlanta
Decatur, Georgia, 30033, United States
Snake River Research
Idaho Falls, Idaho, 83404, United States
Metro Infectious Disease Consultants, LLC
Burr Ridge, Illinois, 60527, United States
DM Clinical Research
Oak Lawn, Illinois, 60453, United States
Baptist Health Research
Lexington, Kentucky, 40503, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mercury Street Medical
Butte, Montana, 59701, United States
Quality Clinical Research, Inc
Omaha, Nebraska, 68114, United States
Weill Cornell Medicine
New York, New York, 10021, United States
IMA Clinical Research
Mount Airy, North Carolina, 27030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC
Annandale, Virginia, 22003, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- An open label sentinel cohort will be followed by a double-blind placebo-controlled main cohort.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2022
First Posted
April 15, 2022
Study Start
August 29, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share