Actively Recruiting
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence
Led by Lumen Bioscience, Inc. · Updated on 2026-02-10
375
Participants Needed
16
Research Sites
26 weeks
Total Duration
On this page
Sponsors
L
Lumen Bioscience, Inc.
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating LMN-201 in adults recently diagnosed with Clostridioides difficile infection (CDI) to assess its safety, tolerability, and effectiveness in preventing the infection from coming back. This study is being conducted at multiple sites and compares LMN-201 with a placebo in participants who are also receiving standard antibiotic treatments for CDI. The purpose is to find better ways to reduce CDI recurrence and improve patient outcomes. LMN-201 is an oral treatment made from dried spirulina that has been engineered to produce proteins that bind and neutralize C. difficile toxin B and an enzyme that destroys the bacteria's cell wall. Participants will be randomly assigned to receive either LMN-201 or placebo capsules alongside their usual antibiotic therapy for up to 28 days. The study includes a sentinel cohort followed by a randomized, double-blind, placebo-controlled phase to carefully compare the treatments. During the study, participants will be monitored for up to 16 weeks after starting therapy to see if they achieve a global cure, meaning no recurrence of infection. Researchers will collect data on symptoms, safety, and how well participants follow the treatment regimen. Participants need access to a smartphone for study procedures and will be followed regularly to assess outcomes and any side effects until the study concludes.
CONDITIONS
Brief Title
LMN-201 for Prevention of C. Difficile Infection Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosis of CDI with 3 or more loose or watery bowel movements per day and positive stool C. difficile toxin B test within 7 days before first dose
- Signed and dated informed consent form provided
- Scheduled to receive or planning to receive up to 28 days of standard antibiotic therapy for CDI (fidaxomicin, metronidazole, or vancomycin)
- May be on systemic antibiotics for infections unrelated to gastrointestinal tract
- Able to take oral medication and willing to follow study medication schedule
- Willing and able to comply with study procedures and available for study duration
- Access to a mobile smartphone
- Females of reproductive potential must use highly effective contraception for at least 4 weeks before screening and during study participation plus 4 weeks after study drug
- Males of reproductive potential must agree to use condoms or other effective contraception during study and for 4 weeks after study drug
You will not qualify if you...
- Fulminant C. difficile colitis
- Admitted or expected to be admitted to intensive care unit
- Underlying gastrointestinal disorders causing diarrhea (e.g., ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome, pancreatic insufficiency, enteric parasitic or viral infections, bacterial enteritis)
- Neutropenia with absolute neutrophil count below 1000 per microliter
- Treatment in past 3 months with therapies affecting study outcome (e.g., bezlotoxumab, C. difficile vaccine, SER-109, CP101, VE303, fecal microbiota transplant, oral exchange resins, prolonged mu-agonist opioid or anticholinergic use for diarrhea)
- Planned antibiotic therapy for CDI longer than 28 days
- Pregnancy, expected pregnancy, or breastfeeding
- Inability or unwillingness to swallow capsules due to swallowing disorder
- Inability to pass capsules into small intestine due to gastroparesis, vomiting, or anatomical narrowing
- Psychiatric illness affecting compliance
- Status as inmate or resident of mental health or substance abuse program
- Terminal illness with life expectancy under 24 weeks
- Significant co-morbid disease making participation unsafe or unlikely to complete
- Any condition jeopardizing safety, rights, or study results as judged by investigator
- Use of probiotics or food supplements is allowed
- Participants with malignancy and good life expectancy are not excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive LMN-201 or placebo to prevent recurrence of C. difficile infection while continuing standard antibiotic therapy.
Weekly visits for up to 4 weeks
Duration - Up to 16 weeks after initiation of therapy
Participants are monitored for up to 16 weeks after starting therapy to assess global cure and recurrence of infection.
Periodic follow-up visits
Trial Site Locations
Total: 16 locations
1
Kaiser Permanente
Escondido, California, United States, 90027
Actively Recruiting
2
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Actively Recruiting
3
Gastroenterology Center of Connecticut
Hamden, Connecticut, United States, 06518
Actively Recruiting
4
GI PROS Research
Naples, Florida, United States, 34102
Actively Recruiting
5
Metro Infectious Disease Consultants - Atlanta
Decatur, Georgia, United States, 30033
Actively Recruiting
6
Snake River Research
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
7
Metro Infectious Disease Consultants, LLC
Burr Ridge, Illinois, United States, 60527
Actively Recruiting
8
DM Clinical Research
Oak Lawn, Illinois, United States, 60453
Actively Recruiting
9
Baptist Health Research
Lexington, Kentucky, United States, 40503
Actively Recruiting
10
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
11
Mercury Street Medical
Butte, Montana, United States, 59701
Actively Recruiting
12
Quality Clinical Research, Inc
Omaha, Nebraska, United States, 68114
Actively Recruiting
13
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
14
IMA Clinical Research
Mount Airy, North Carolina, United States, 27030
Actively Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC
Annandale, Virginia, United States, 22003
Actively Recruiting
Research Team
C
Carl Mason
A
Asa Davis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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